Auricular Acupuncture Therapy for Stage I of Shoulder Hand Syndrome (SHS) After Ischemic Stroke: Study Protocol for a Randomized, Sham-controlled, Patient-blinded, Clinical Trial

Abstract Background: Shoulder hand syndrome (SHS) is one of the common complications after a stroke, with the incidence rate up to 75% in China. The stage Ⅰ level is manifested as chronic pain and limitation of movement, which could cause irreversible muscle atrophy, joint deformation and even loss of motor function if progress to stage Ⅱ and Ⅲ. Auricular acupuncture, as one important component of traditional Chinese medicine (TCM) is a micro acupuncture therapy which combines acupuncture and holographic theory. However, the clinical efficacy of auricular acupuncture is still controversial and the length of improvement by auricular acupuncture has not been validated by clinical studies. Therefore, this study aims to evaluate the efficacy and duration of auricular acupuncture for pain relief and for motor function improvement in stage Ⅰ of SHS after ischemic stroke.Methods:This is a randomized, sham-controlled, patient-blinded trial. A total of 108 eligible patients with stage Ⅰ of SHS after ischemic stroke will be recruited from September 2018 to December 2020 and will be randomly allocated to three groups, A, B, or C, with a 1:1:1 ratio. Only body acupuncture will be applied in group A as a control group. Non-needle-insertion for sham auricular acupuncture will be combined with body acupuncture and applied to group B, whereas auricular acupuncture combined with body acupuncture will be applied in group C. Patients will be treated for 30 min per session, for 5 sessions per week for 3 weeks, and followed up for 6 weeks. The primary outcome will be the visual analog scale (VAS) for the shoulder and hand pain. The secondary outcomes will include the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) and Modified Brathel Index (MBI). Eligible patients would be evaluated before treatment, immediately after treatment, and followed up after 1 week, 2 weeks and 6 weeks to verify the duration of auricular acupuncture effect.Discussion:This trial will help to identify the effectiveness and duration of auricular acupuncture effect for stage Ⅰ of SHS after ischemic stroke. Trial registration:www.chictr.org.cn, Chinese Clinical Trial Registry: ChiCTR2000037946. Retrospectively registered on 4 March 2020.

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Effect of Nudge-Based Intervention on Adherence to Physician Visit Recommendations and Early Health Outcomes among Individuals Identified with Chronic Kidney Disease in Screens

Journal of the American Society of Nephrology ◽

10.1681/asn.2021050664 ◽

2021 ◽

pp. ASN.2021050664

Author(s):

Shingo Fukuma ◽

Shusaku Sasaki ◽

Masataka Taguri ◽

Rei Goto ◽

Toshihiro Misumi ◽

...

Keyword(s):

Clinical Trial ◽

Health Outcomes ◽

Behavioral Economics ◽

Physician Visit ◽

Group Versus ◽

Control Group ◽

Trial Registry ◽

Clinical Trial Registry ◽

Screening Programs ◽

Early Health

BackgroundAlthough CKD screening programs have been provided in many settings, little is known as to how we can effectively translate those screening programs into improved health.MethodsWe conducted a randomized clinical trial on national health screening for CKD in Japan between April 2018 and March 2019. A total of 4011 participants in CKD screening programs aged 40–63 years were randomly assigned to two interventions or the control, with a ratio of 2:2:1, respectively: (1) the nudge-based letter that contained a message on the basis of behavioral economics, (2) the clinical letter including general information about CKD risks, and (3) the control (informed only of the screening results). The main outcome was adherence to a recommended physician visit within 6 months of the intervention. The secondary outcomes were eGFR, proteinuria, and BP 1 year after the intervention.ResultsCompared with the control group, the probability of undergoing a recommended physician visit was higher among participants who received the nudge-based letter (19.7% for the intervention group versus 15.8% for the control; difference, +3.9 percentage points [pp]; 95% CI, +0.8 to +7.0; P=0.02) and the clinical letter (19.7% versus 15.8%; difference, +3.9 pp; 95% CI, +0.8 to +7.0; P=0.02). We found no evidence that interventions were associated with improved early health outcomes.ConclusionsThe behavioral economics intervention tested in this large RCT had limited effect on changing behavior or improving health outcomes. Although the approach has promise, this study demonstrates the challenge of developing behavioral interventions that improve the effectiveness of CKD screening programs.Clinical Trial registry name and registration number: University Hospital Medical Information Network Clinical Trial Registry, UMIN000035230

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Abstract TP138: Repeated Bilateral Multifocal Cortical Magnetic Stimulation with a New Wearable Transcranial Stimulator in Chronic Ischemic Stroke

Stroke ◽

10.1161/str.48.suppl_1.tp138 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Santosh Helekar ◽

Blessy John ◽

Rafferty Laredo ◽

Cynthia Card ◽

Charles McCane ◽

...

Keyword(s):

Clinical Trial ◽

Ischemic Stroke ◽

Grip Strength ◽

Pulse Duration ◽

Motor Function ◽

Gait Speed ◽

Magnetic Stimulation ◽

Cortical Reorganization ◽

In Cis

Introduction: Repetitive transcranial magnetic stimulation (rTMS) treatment of ipsilesional (IL) or contralesional (CL) cortex combined with occupational/physical therapy (OT/PT) shows significant promise in chronic ischemic stroke (CIS). Here we describe a multifocal cortical magnetic stimulation protocol with a new wearable device called transcranial rotating permanent magnet stimulator (TRPMS) for a pilot clinical trial in CIS, and present preliminary results in one patient. Hypothesis: Simultaneous repeated excitatory and inhibitory stimulations of IL and CL cortical sites, respectively cause perilesional functional cortical reorganization with recovery of motor function in CIS. Methods: After informed consent, we treated a 58-year old male patient with a right middle cerebral artery thromboembolic infarct causing left sided hemiparesis. At the start of TRPMS treatment 19 months after the stroke he had a stable baseline on motor function tests. The treatment consisted of 4 two-week sessions (with intervening one-week rest periods) of daily (on week days) 40 min TRPMS stimulation (5 Hz, 25 ms pulse duration at 4 perilesional cortical sites, and 0.2 Hz, 100 ms pulse duration at 2 CL primary motor cortical sites) accompanied by OT/PT. Pretreatment, posttreatment and follow-up assessments were functional magnetic resonance imaging (fMRI) during attempted gripping movements, and grip strength, gait speed and Fugl-Meyer (FM) scale testing. Results: After the 2 nd treatment session movement-related fMRI showed increasing levels of neural activation of the stimulated intact cortex surrounding the lesion. Grip strength of the affected hand increased ~2.5 fold. Gait speed increased by ~15%. Left lower extremity motor function and sensation measures on the FM scale showed sustained increase by ~17% and ~30%, respectively. These changes persisted above the pretreatment levels at the 3-month follow-up. There were no adverse effects. Conclusions: These findings suggest that the new TRPMS protocol might bring about some degree of functional cortical reorganization and motor recovery in CIS. We have therefore launched a randomized double-blind sham treatment-controlled clinical trial involving a four-week TRPMS treatment in 30 CIS patients.

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Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

10.21203/rs.3.rs-16499/v2 ◽

2020 ◽

Author(s):

Jun Ni ◽

Huisheng Chen ◽

Guofang Chen ◽

Yong Ji ◽

Fei Yi ◽

...

Keyword(s):

Ischemic Stroke ◽

Thrombolytic Therapy ◽

Acute Ischemic Stroke ◽

Barthel Index ◽

Controlled Trial ◽

Survival Rates ◽

Control Group ◽

Efficacy And Safety ◽

Clinical Trial Registry ◽

Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

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Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial

International Journal of Dentistry ◽

10.1155/2021/8896408 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

Muhanad AlHareky ◽

Jehan AlHumaid ◽

Sumit Bedi ◽

Maha El Tantawi ◽

Mazin AlGahtani ◽

...

Keyword(s):

Clinical Trial ◽

Test Group ◽

The United States ◽

Nerve Fibers ◽

T Test ◽

Control Group ◽

Controlled Clinical Trial ◽

Clinical Trial Registry ◽

Dental Anesthesia ◽

Gate Control Theory

Background. The ‘‘gate control’’ theory suggests pain can be reduced by simultaneous activation of larger diameter nerve fibers using appropriate coldness, warmth, rubbing, pressure, or vibration. This study investigated the efficacy of a device combining cold and vibration, for needle-related procedural pain in children. Methodology. A total of 51 children aged 5–12 years participated in this randomized controlled clinical trial. Half of the children were in the control group and received maxillary buccal infiltration, by injecting 1.8 ml of 2% lidocaine with 1 : 100,000 adrenaline using topical anesthesia 20% benzocaine gel for 15 seconds, while the other half were in the test group and received the same anesthesia using a commercially available external cold and a vibrating device. A face version of Visual Analogue Scale (VAS) was used as a subjective measure to assess the child’s pain experience. The parents were requested to evaluate the child’s ability to tolerate pain using a behavioral/observational pain scale. Sound, Eyes, and Motor (SEM) scale and Faces, Legs, Activity, Cry, and Consolability (FLACC) scale were used to record the child’s pain as perceived by the external evaluator. T-test or Mann–Whitney U-test was used for scale variables, paired sample T-test or Wilcoxon rank t-test was used for before and after data, and chi-square was used for categorical variable, based on the results of normality test. Results. The results showed a statistically significant reduction in pain after the injection for the test group compared with control using VAS scale (mean = 6.68 (1.09) and 8.42 (0.50); p = 0.001 ) and FLACC scale (mean = 5.92 (1.05) and 8.16 (0.54); p = 0.002 ), but not when using SEM scale (mean 3.22 (0.42) and 4.24 (2.74); p = 0.08 ). Conclusions. Combined external cold and vibrating devices can be an effective alternative in reducing experienced pain and fear in children undergoing infiltration dental anesthesia. This study was registered with clinical trial registry of the United States National Institutes of Health (NIH) at ClinicalTrials.gov (NCT03953001).

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Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical study

Trials ◽

10.1186/s13063-019-3967-2 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Zhi-peng Xiao ◽

ke Jin ◽

Jie-qing Wan ◽

Yong Lin ◽

Yao-hua Pan ◽

...

Keyword(s):

Clinical Trial ◽

Blood Flow ◽

Cerebral Blood Flow ◽

Ischemic Stroke ◽

Multimodal Imaging ◽

Imaging Techniques ◽

Trial Registry ◽

Clinical Trial Registry ◽

Cerebrovascular Reserve ◽

Randomized Controlled

Abstract Background Cerebrovascular reactivity (CVR) is the change in cerebral blood flow in response to a vaso-active stimulus, and may assist the treatment strategy of ischemic stroke. However, previous studies reported that a therapeutic strategy for stroke mainly depends on the degree of vascular stenosis with steady-state vascular parameters (e.g., cerebral blood flow and CVR). Hence, measurement of CVR by multimodal imaging techniques may improve the treatment of ischemic stroke. Methods/design This is a prospective, randomized, controlled clinical trial that aimed to examine the capability of multimodal imaging techniques for the evaluation of CVR to improve treatment of patients with ischemic stroke. A total of 66 eligible patients will be recruited from Renji Hospital, Shanghai Jiaotong University School of Medicine. The patients will be categorized based on CVR into two subgroups as follows: CVR > 10% group and CVR < 10% group. The patients will be randomly assigned to medical management, percutaneous transluminal angioplasty and stenting, and intracranial and extra-cranial bypass groups in a 1:1:1 ratio. The primary endpoint is all adverse events and ipsilateral stroke recurrence at 6, 12, and 24 months after management. The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months. Discussion Measurement of cerebrovascular reserve by multimodal image is recommended by most recent studies to guide the treatment of ischemic stroke, and thus its efficacy and evaluation accuracy need to be established in randomized controlled settings. This prospective, parallel, randomized, controlled registry study, together with other ongoing studies, should present more evidence for optimal individualized accurate treatment of ischemic stroke. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16009635; Registered on 16 October 2016. All items are from the World Health Organization Trial Registration Data Set and registration in the Chinese Clinical Trial Registry: ChiCTR-IOR-16009635.

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The Effect of Medium Chain Triglycerides on Time to Nutritional Ketosis and Symptoms of Keto-Induction in Healthy Adults: A Randomised Controlled Clinical Trial

Journal of Nutrition and Metabolism ◽

10.1155/2018/2630565 ◽

2018 ◽

Vol 2018 ◽

pp. 1-9 ◽

Cited By ~ 10

Author(s):

Cliff J. d C. Harvey ◽

Grant M. Schofield ◽

Micalla Williden ◽

Joseph A. McQuillan

Keyword(s):

Clinical Trial ◽

Healthy Adults ◽

Control Group ◽

Controlled Clinical Trial ◽

Medium Chain Triglycerides ◽

Clinical Trial Registry ◽

Medium Chain ◽

Low Carbohydrate ◽

Randomised Controlled ◽

Beta Hydroxybutyrate

Medium chain triglycerides (MCTs) are ketogenic and might reduce adverse effects of keto-induction and improve time to ketosis and the tolerability of very low carbohydrate diets. This study investigates whether MCT supplementation improves time to nutritional ketosis (NK), mood, and symptoms of keto-induction. We compared changes in beta-hydroxybutyrate (BOHB), blood glucose, symptoms of keto-induction, and mood disturbance, in 28 healthy adults prescribed a ketogenic diet, randomised to receive either 30 ml of MCT, or sunflower oil as a control, three times per day, for 20 days. The primary outcome measured was the achievement of NK (≥0.5 mmol·L−1 BOHB). Participants also completed a daily Profile of Mood States and keto-induction symptom questionnaire. MCT resulted in higher BOHB at all time points and faster time to NK, a result that failed to reach significance. Symptoms of keto-induction resulted from both diets, with a greater magnitude in the control group, except for abdominal pain, which occurred with greater frequency and severity in the MCT-supplemented diet. There was a possibly beneficial effect on symptoms by MCT, but the effect on mood was unclear. Based on these results, MCTs increase BOHB compared with LCT and reduce symptoms of keto-induction. It is unclear whether MCTs significantly improve mood or time to NK. The trial was registered by the Australia New Zealand Clinical Trial Registry ACTRN12616001099415.

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Revisit the Effectiveness of Educational Kinesiology on Stress and Anxiety Amelioration in Kindergarteners With Special Needs: A Nonrandomized Trial

10.21203/rs.3.rs-407301/v1 ◽

2021 ◽

Author(s):

Pui Lun Alan TAI ◽

Kwok Wai Way LAU

Keyword(s):

Clinical Trial ◽

Special Needs ◽

Scientific Evidence ◽

Intervention Group ◽

Control Group ◽

Clinical Trial Registry ◽

Open Label ◽

Post Intervention ◽

Educational Kinesiology ◽

Registration Number

Abstract Although educational kinesiology is a popular intervention aims to improve brain functioning via physical movements, it lacks supporting scientific evidence. This study explores the effect of educational kinesiology on the changes in stress and anxiety markers in kindergarteners with special needs using psychometrics and biological measures. This open label non-randomized clinical trial was registered retrospectively in the Chinese Clinical Trial Registry (registration number: ChiCTR2000036305, url: http://www.chictr.org.cn/showproj.aspx?proj=58067, registration date: 22/08/2020). Thirty-seven kindergarteners with special needs (3.5-6.5 years old) were assigned to either the intervention group, which received one-hour educational kinesiology intervention weekly for a total of 10 weeks, or the wait-list control group. Scores of Parent-rated Preschool Anxiety Scale (PAS-TC), salivary cortisol and oxytocin levels were obtained pre- and post-intervention. After controlling baseline, the changes in oxytocin levels remained significantly different between groups (F1,35 = 5.590, p = 0.020, eta2 = 0.145), but not in cortisol levels (F1,35 = 0.364, p = 0.550, eta2 = 0.01). PAS-TC showed significant improvement in anxiety levels after the intervention in the intervention group (X2 = 4.367, p = 0.037, φ = 0.344, p = 0.037). Findings from both subjective and objective measures indicate a plausible anti-stress and anxiety effect in kindergarteners with special needs.

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Evaluating the Long-Term Efficacy of Acupuncture Therapy for Subacute Poststroke Aphasia: Study Protocol for a Randomized, Blinded, Controlled, Multicentre Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/8880590 ◽

2021 ◽

Vol 2021 ◽

pp. 1-13

Author(s):

Xiaolin Li ◽

Ying Gao ◽

Chi Zhang ◽

Qingsu Zhang ◽

Xiyan Xin ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Acupuncture Therapy ◽

Long Term Results ◽

Control Group ◽

Acupuncture Points ◽

Term Efficacy ◽

Secondary Outcomes

Background. Poststroke aphasia (PSA) is a disabling condition that decreases the quality of life, and the duration of the disease harms the quality of life of PSA patients. Acupuncture has been widely employed for PSA. There is some evidence for the immediate treatment efficacy of acupuncture for PSA; however, long-term results after acupuncture may be poorer. Methods. This is a multicentre, randomized, blinded, nonacupoint (NA) acupuncture controlled, multimodal neuroimaging clinical trial. A total of 48 subjects with subacute PSA will be randomly assigned to an acupoint group or an NA control group. The acupoint group will receive acupuncture with normal needling at DU20, EX-HN1, HT5, GB39, EX-HN12, EX-HN13, and CV23. The NA control group will receive acupuncture in locations not corresponding to acupuncture points as sham acupoints. Both groups will receive identical speech and language therapy thrice a week for four weeks. The primary outcome will be the change in the aphasia quotient (AQ) score measured by the Western Aphasia Battery (WAB) test during the 12th week after randomization. Participants will be blindly assessed at prerandomization (baseline) and 4 weeks, 12 weeks, and 24 weeks after randomization. The secondary outcomes include the Boston Diagnostic Aphasia Examination (BDAE) score, the Disease Prognosis Scale score for ischaemic stroke, etc. Magnetic resonance imaging (MRI) and electroencephalogram (EEG) will also be performed at 4-time intervals as secondary outcomes. All scores and image evaluations will be taken at the same point as the linguistic evaluation. The multilevel evaluation technique will be used to assess the long-term efficacy of acupuncture therapy. MRI scans and EEG will be used to assess acupuncture-related neuroplasticity changes. Discussion. The results from our trial will help to supply evidence for the long-term acupuncture effects for PSA over a long follow-up period. It will provide valuable information for future studies in the field of PSA treatment. The trial was registered at the Chinese Clinical Trial Registry on 16 March 2020 (ChiCTR2000030879).

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Effect of Specific Acupuncture Therapy Combined with Rehabilitation Training on Incomplete Spinal Cord Injury: A Randomized Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/5671998 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Feng Xiong ◽

Jingkang Lu ◽

Hongxia Pan ◽

Fengyi Wang ◽

Yaqin Huang ◽

...

Keyword(s):

Clinical Trial ◽

Spinal Cord ◽

Spinal Cord Injury ◽

Acupuncture Therapy ◽

Acupuncture Treatment ◽

Control Group ◽

Motor Score ◽

Rehabilitation Training ◽

Sensory Score ◽

Cord Injury

Acupuncture therapies were used to treat spinal cord injury (SCI) and its complications. To assess the effect of a specific acupuncture therapy combined with rehabilitation training for inpatients with incomplete SCI, we conducted an assessor-blinded, randomized controlled clinical trial in the Department of Rehabilitation Medicine Center in West China Hospital, Sichuan University. Seventy-two participants diagnosed with incomplete SCI were randomly assigned into 3 groups of 24 patients each, with data collection completed in December, 2019. Participants were randomly assigned (1 : 1 : 1) to 3 groups to receive treatment for 4 weeks, 5 times/week of acupuncture for Continuous Acupuncture Treatment (CAT) group, 3 times/week for Intermittent Acupuncture Treatment (IAT) group, and no acupuncture for Control group; all 3 groups received routine rehabilitation training. The primary outcome was the change of American Spinal Injury Association (ASIA) motor score from baseline to week 4. Secondary outcomes included sensory score, Modified Barthel Index (MBI). At week 4, CAT group had a higher motor score and MBI score increase than the control group (mean difference 10.52, 17.36; p < 0.001, p < 0.01, respectively). CAT group had more increase in motor score and MBI than IAT group (mean difference 5.55, 14.77; p < 0.05, p < 0.05, respectively). But the difference among groups in the increase of sensory score was not statistically significant. Acupuncture resulted in a higher motor score and MBI after 4 weeks. And the dosage of 5/week led to more improvement in motor score and MBI than that of 3/week. The results suggested that a dosage of 5/week of acupuncture is safe and more effective for SCI than 3/week. But further research is needed to determine the best intervention dosage, long-term efficacy, and underlying mechanism. This trial is registered with ChiCTR1900021530.

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HEALING RATE IN DIABETIC FOOT ULCERS TREATED WITH BIOMEMBRANE AND HYDROCOLLOID POWDER: RANDOMIZED CLINICAL TRIAL

ESTIMA Brazilian Journal of Enterostomal Therapy ◽

10.30886/estima.v19.986_in ◽

2021 ◽

Author(s):

Manuela de Mendonça Figueirêdo Coelho ◽

Luciana Catunda Gomes de Menezes ◽

Shérida Karanini Paz de Oliveira ◽

Ana Débora Alcantara Coêlho Bonfim ◽

Viviane Mamede Vasconcelos Cavalcante ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Healing Rate ◽

Foot Ulcers ◽

Calotropis Procera ◽

Control Group ◽

Controlled Clinical Trial ◽

Diabetic Foot Ulcers ◽

Clinical Trial Registry ◽

Experimental Group

Objective: to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

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