A Diabetic Foot Ulcer Pilot Study

Background: Silicone gel sheeting is an effective therapeutic intervention in the management of scar tissue. This pilot study was designed to examine the effect of silicone gel sheeting in preventing reulceration at former wound sites in diabetic patients. Methods: Thirty patients with diabetes and a healed plantar neuropathic foot ulcer were enrolled and investigated in this randomized controlled trial. Participants with a newly healed ulcer were assigned to use either silicone gel sheeting or emollient cream daily for 3 months. Results: Compared with emollient cream use, the use of silicone gel sheeting did not diminish and may have potentially increased the risk of reulceration. Conclusions: Silicone gel sheeting does not seem to reduce the risk of reulceration in diabetic patients. The results of this trial should be viewed with caution given the small sample size. (J Am Podiatr Med Assoc 101(2): 116–123, 2011)

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A randomized controlled trial of the safety and efficacy of a topical gentamicin–collagen sponge in diabetic patients with a mild foot ulcer infection

SAGE Open Medicine ◽

10.1177/2050312118773950 ◽

2018 ◽

Vol 6 ◽

pp. 205031211877395 ◽

Cited By ~ 8

Author(s):

Ilker Uçkay ◽

Benjamin Kressmann ◽

Sébastien Di Tommaso ◽

Marina Portela ◽

Heba Alwan ◽

...

Keyword(s):

Antimicrobial Therapy ◽

Diabetic Foot ◽

Wound Care ◽

Controlled Trial ◽

Pilot Trial ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Collagen Sponge ◽

Diabetic Patients ◽

Topical Antibiotic

Objectives: The initial phase of infection of a foot ulcer in a person with diabetes is often categorized as mild. Clinicians usually treat these infections with antimicrobial therapy, often applied topically. Some experts, however, believe that mild diabetic foot ulcer infections will usually heal with local wound care alone, without antimicrobial therapy or dressings. Methods: To evaluate the potential benefit of treatment with a topical antibiotic, we performed a single-center, investigator-blinded pilot study, randomizing (1:1) adult patients with a mild diabetic foot ulcer infection to treatment with a gentamicin–collagen sponge with local care versus local care alone. Systemic antibiotic agents were prohibited. Results: We enrolled a total of 22 patients, 11 in the gentamicin–collagen sponge arm and 11 in the control arm. Overall, at end of therapy, 20 (91%) patients were categorized as achieving clinical cure of infection, and 2 (9%) as significant improvement. At the final study visit, only 12 (56%) of all patients achieved microbiological eradication of all pathogens. There was no difference in either clinical or microbiological outcomes in those who did or did not receive the gentamicin–collagen sponge, which was very well tolerated. Conclusion: The results of this pilot trial suggest that topical antibiotic therapy with gentamicin–collagen sponge, although very well tolerated, does not appear to improve outcomes in mild diabetic foot ulcer infection.

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IPSWICH TOUCH TEST SEBAGAI METODE SEDERHANA DALAM MENDETEKSI DIABETIC POLYNEUROPATHY (DPN) : LITERATURE REVIEW

Jurnal Ilmiah Perawat Manado (Juiperdo) ◽

10.47718/jpd.v8i02.1065 ◽

2021 ◽

Vol 8 (02) ◽

pp. 34-46

Author(s):

Paridah Paridah ◽

Ana Damayanti ◽

Indrawati Indrawati ◽

Grace A Merentek ◽

Sofyawati Yunus

Keyword(s):

Systematic Review ◽

Diabetic Foot ◽

Controlled Trial ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Diabetic Polyneuropathy ◽

Screening Methods ◽

Diabetic Patients ◽

High Negative Predictive Value ◽

Diabetes Melitus

ABSTRAK Penderita Diabetes Melitus (DM) memiliki potensi untuk menyebabkan banyak komplikasi baik yang dikelola dengan baik atau tidak dan banyak dari mereka tidak menyadari hal tersebut. Gangguan sensasi pada ekstermitas bawah, merupakan gejala awal komplikasi DM yang akan menjadi cikal bakal terjadinya Diabetic Foot Ulcer (DFU). Studi literature ini bertujuan untuk menampilkan hasil dari beberapa penelitian yang menggunakan IpTT dalam penelitian terhadap deteksi neuropati pada pasien DM. Metodologi yang digunakan untuk tinjauan ini adalah hasil telaah dari beberapa penelitian tentang ”Ipswich Touch Test” yang dipublikasi pada tiga data base. Kami mengkategorikan studi berdasarkan tipe DM, metode penelitian yang dilakukan adalah ah Randomize Controlled Trial dengan systematic review. Kami membandingkan kesimpulan penelitian berdasarakan tingkat sensibilitas klien diabetes pada daerah perifer/DPN dengan IpTT. Temuan kami menunjukkan bahwa IpTT merupakan salah satu metode yang reliabel, valid mudah, murah dan tidak menimbulkan bahaya serta dapat diajarkan kepada pasien dan keluarga dalam mendeteksi risiko Diabetic foot ulcer (DFU) pada penderita diabetes. IpTT juga memiliki nilai prediktif negatif yang tinggi dan keakuratan yang sangat baik bila dibandingkan dengan metode skrining standar mendukung perannya sebagai alat skrining untuk mendeteksi risiko DFU pada pasien diabetes. Kesimpulannya adalah IpTT merupakan salah satu metode untuk menilai tingkat sensibilitas pasien DM yang cukup sensitif, efektif, spesifik, mudah dilakukan tidak memerlukan biaya maupun alat serta tidak menimbulkan bahaya baik bagi pasien maupun pemeriksa dan dapat dilakukan oleh siapapun. Kata kunci: Ipswich Touch Test, neuropati, sensibilitas ABSTRACT People with diabetes mellitus (DM) have the potential to cause many complications no matter how well-managed and most of them are unaware. Impaired sensation in the lower extremity, is an early warning of DM complications that will become a Diabetic Foot Ulcer (DFU). The aim of this study is to present the results from several studies using IPTT in research neuropathy of DM patients detection. The methodology used for this review is the result of several studies on the "Ipswich Touch Test" published on three data bases. We categorize studies based on type of DM, the research method is Randomize Controlled Trial with a systematic review. We compared the study conclusions based on the level of diabetes client sensibility in the peripheral area/DPN with IpTT. Our finding show that IpTT is a reliable, easy, inexpensive and harmless method and it can be taught to the patients and families in detecting the risk of diabetic foot ulcer (DFU). IpTT also has a high negative predictive value and excellent accuracy when it compared to standard screening methods for supporting role as screening tool to detect the risk of DFU in diabetic patients. The conclusion is the IpTT as a method for assessing the level of DM patient sensibility is quite sensitive, effective, specific, easy to do, cost-free, without tools and harmless to both patients and examiners and it can be done simply by almost anyone. Kata Kunci: Ipswich Touch Test, neuropathy, sensibility

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The Effects of Silver-Releasing Foam Dressings on Diabetic Foot Ulcer Healing

Journal of Clinical Medicine ◽

10.3390/jcm10071495 ◽

2021 ◽

Vol 10 (7) ◽

pp. 1495

Author(s):

Yu-Chi Wang ◽

Hsiao-Chen Lee ◽

Chien-Lin Chen ◽

Ming-Chun Kuo ◽

Savitha Ramachandran ◽

...

Keyword(s):

Wound Healing ◽

Diabetic Foot ◽

Healing Rate ◽

Early Period ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Wound Management ◽

Control Group ◽

Diabetic Patients ◽

High Morbidity

Diabetic foot ulcers (DFUs) are a serious complication in diabetic patients and lead to high morbidity and mortality. Numerous dressings have been developed to facilitate wound healing of DFUs. This study investigated the wound healing efficacy of silver-releasing foam dressings versus silver-containing cream in managing outpatients with DFUs. Sixty patients with Wagner Grade 1 to 2 DFUs were recruited. The treatment group received silver-releasing foam dressing (Biatain® Ag Non-Adhesive Foam dressing; Coloplast, Humlebaek, Denmark). The control group received 1% silver sulfadiazine (SSD) cream. The ulcer area in the silver foam group was significantly reduced compared with that in the SSD group after four weeks of treatment (silver foam group: 76.43 ± 7.41%, SSD group: 27.00 ± 4.95%, p < 0.001). The weekly wound healing rate in the silver foam group was superior to the SSD group during the first three weeks of treatment (p < 0.05). The silver-releasing foam dressing is more effective than SSD in promoting wound healing of DFUs. The effect is more pronounced in the initial three weeks of the treatment. Thus, silver-releasing foam could be an effective wound dressing for DFUs, mainly in the early period of wound management.

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The Symbiotic Mutualism between Co-Creation and Entrepreneurship

Sustainability ◽

10.3390/su13116285 ◽

2021 ◽

Vol 13 (11) ◽

pp. 6285

Author(s):

Sandra Misiak-Kwit ◽

Małgorzata Wiścicka-Fernando ◽

Kelaniyage Shihan Dilruk Fernando

Keyword(s):

Pilot Study ◽

Small Sample Size ◽

Strong Association ◽

Sampling Technique ◽

Small Sample ◽

Entrepreneurial Intentions ◽

Added Value ◽

Primary Data ◽

Exploratory Research ◽

Symbiotic Mutualism

In this manuscript, the authors aim to explore firstly the association between entrepreneurial mindset and co-creation experience, secondly the association between co-creation experience and entrepreneurial intentions, and thirdly the association between entrepreneurial mindset and entrepreneurial intentions within the sustainability context. In this paper, the authors present the results of the pilot study. Primary data were collected from 500 university students from China, Georgia, Poland, Romania, and Sri Lanka by using a convenient sampling technique, and a literature review was the primary method of the concept development. The authors selected the above-mentioned countries to collect primary data by using a convenient sampling technique based on accessibility; they also visited all analysed countries in order to conduct the pilot survey personally. Descriptive statistics and the Spearman’s rank correlation coefficient were applied as primary statistical methods. The findings reveal that there is a very strong association between co-creation experience and entrepreneurial intentions, a very weak negative association between entrepreneurial mindset and co-creation experience, and, surprisingly, a weak association between entrepreneurial mindset and entrepreneurial intentions. The added value of the conducted pilot research involves filling in a gap regarding the relationship between experience and the subjective norm. In the presented pilot research, co-creation experience was compared with not only entrepreneurial mindset but with entrepreneurial intentions as well. An additional value of this exploratory research is compiling an international comparison. The main contribution of this pilot study is examining the symbiotic mutualism between co-creation and entrepreneurship. Among many platforms of associations, the following can be differentiated: creativity, innovativeness, openness, engagement, awareness, motivation, trust (level of social capital), and recognizing the significance of social and sustainable development objectives. Due to the small sample size, the results cannot be generalised. Results refer only to the respondents. However, the findings of the pilot study are the basis for further research studies on symbiotic mutualism between entrepreneurship and co-creation.

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Blinding in electric current stimulation in subacute neglect patients with current densities of 0.8 A/m2: a cross-over pilot study

BMC Research Notes ◽

10.1186/s13104-020-05421-7 ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Anna Gorsler ◽

Ulrike Grittner ◽

Nadine Külzow ◽

Torsten Rackoll

Keyword(s):

Pilot Study ◽

Electric Fields ◽

Standard Care ◽

Small Sample Size ◽

Small Sample ◽

Related Factors ◽

Attentional Deficits ◽

Age Related ◽

Current Densities ◽

Improve Standard

Abstract Objective Neglect after stroke is a disabling disorder and its rehabilitation is a major challenge. Transcranial direct current stimulation (tDCS) seems to be a promising adjuvant technique to improve standard care neglect therapy. Since electric fields are influenced by age-related factors, higher current densities are probably needed for effective treatment in aged stroke patients. Validation of treatment efficacy requires sham-controlled experiments, but increased current densities might comprise blinding. Therefore, a pilot study was conducted to test sham adequacy when using current density of 0.8 A/m2. Whether especially neglect patients who mainly suffer from perceptual and attentional deficits are able to differentiate beyond chance active from sham tDCS was investigated in a randomized cross-over design (active/sham stimulation) in 12 early subacute patients with left-sided hemineglect. Stimulation (0.8 A/m2) was performed simultaneous to standard care neglect therapy. Results Odds ratio of correct guessing an atDCS condition compared to wrongly judge an atDCS condition as sham was 10.00 (95%CI 0.65–154.40, p = 0.099). However, given the small sample size and high OR, although likely somewhat overestimated, results require careful interpretation and blinding success in neglect studies with current densities of 0.8 A/m2 should be further confirmed.

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Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT

Gerontology ◽

10.1159/000510903 ◽

2020 ◽

Vol 66 (6) ◽

pp. 542-548

Author(s):

Wendy L. Cook ◽

Penelope M.A. Brasher ◽

Pierre Guy ◽

Stirling Bryan ◽

Meghan G. Donaldson ◽

...

Keyword(s):

Hip Fracture ◽

Small Sample Size ◽

Controlled Trial ◽

Geriatric Care ◽

Small Sample ◽

Community Dwelling ◽

Post Discharge ◽

Mobility Performance ◽

Discharge Care ◽

Comprehensive Geriatric Care

Background: Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care. Objective: To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months. Methods: A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3–12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0–12) at 12 months. Results: We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (n = 26) and usual care (UC, n = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI –0.3 to 2.0, p = 0.13). Adverse events were similar in the 2 groups. Conclusion: The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.

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Perceptions and Understanding of Diabetes Mellitus Technology in Adults with Type 1 or Type 2 DM: A Pilot Survey from Pakistan

Journal of Diabetes Science and Technology ◽

10.1177/19322968211011199 ◽

2021 ◽

pp. 193229682110111

Author(s):

Sarah Nadeem ◽

Uswah Siddiqi ◽

Russell Seth Martins ◽

Kaleemullah Badini

Keyword(s):

Diabetes Mellitus ◽

Pilot Study ◽

Diabetes Care ◽

Online Survey ◽

Small Sample Size ◽

Developed Countries ◽

Small Sample ◽

Cost Of Care ◽

Cross Sectional ◽

Specific Patient

Introduction: Diabetes mellitus technology (DMT) is increasingly used for routine management in developed countries, yet its uptake in developing countries is not as consistent. Multiple factors may influence this, including country specific patient perception regarding DMT. We conducted a pilot study in Pakistan to understand this important question which has not been studied yet. Methods: A cross-sectional pilot study was conducted in Pakistan. An anonymous survey exploring perceptions of diabetes technology was circulated on social media platforms, collecting responses over 2 weeks. Target population included adults (≥18 years) living in Pakistan, with DM1 or 2. Results: A total of 40 responses were received. The majority (36/40) reported using conventional glucometers. Nine used continuous glucose monitoring (CGM). Thirty-two of 40 patients believed DMT improved diabetes care, 22 felt it helped decreased risk of Diabetes-related complications. 15/40 stated that DMT results in increased cost of care. Sixteen reported their diabetes care teams had never discussed wearable DMT options whereas 11 disliked them because they did not want a device on their self. Conclusion: In our pilot study we have identified broad themes of opportunity and challenges to DMT use in Pakistan. Patients’ perceptions regarding DMT were generally positive but significant barriers to its acceptance included high cost, lack of discussion between doctor and patient about available technology and personal hesitation. Limitations of our study include sampling bias (online survey) and small sample size, but this data can help inform larger studies, to look at this important topic in greater detail.

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DIAGNOSIS OF ENDOCRINE DISEASE: The diagnostic performance of adrenal biopsy: a systematic review and meta-analysis

Acta Endocrinologica ◽

10.1530/eje-16-0297 ◽

2016 ◽

Vol 175 (2) ◽

pp. R65-R80 ◽

Cited By ~ 40

Author(s):

Irina Bancos ◽

Shrikant Tamhane ◽

Muhammad Shah ◽

Danae A Delivanis ◽

Fares Alahdab ◽

...

Keyword(s):

Systematic Review ◽

Diagnostic Performance ◽

Small Sample Size ◽

Controlled Trial ◽

Meta Analysis ◽

Small Sample ◽

Cochrane Central Register ◽

Moderate Risk ◽

Adrenal Biopsy ◽

Adrenocortical Carcinomas

ObjectiveTo perform a systematic review of published literature on adrenal biopsy and to assess its performance in diagnosing adrenal malignancy.MethodsMedline In-Process and Other Non-Indexed Citations, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trial were searched from inception to February 2016. Reviewers extracted data and assessed methodological quality in duplicate.ResultsWe included 32 observational studies reporting on 2174 patients (39.4% women, mean age 59.8 years) undergoing 2190 adrenal mass biopsy procedures. Pathology was described in 1621/2190 adrenal lesions (689 metastases, 68 adrenocortical carcinomas, 64 other malignancies, 464 adenomas, 226 other benign, 36 pheochromocytomas, and 74 others). The pooled non-diagnostic rate (30 studies, 2013 adrenal biopsies) was 8.7% (95%CI: 6–11%). The pooled complication rate (25 studies, 1339 biopsies) was 2.5% (95%CI: 1.5–3.4%). Studies were at a moderate risk for bias. Most limitations related to patient selection, assessment of outcome, and adequacy of follow-up. Only eight studies (240 patients) could be included in the diagnostic performance analysis with a sensitivity and specificity of 87 and 100% for malignancy, 70 and 98% for adrenocortical carcinoma, and 87 and 96% for metastasis respectively.ConclusionsEvidence based on small sample size and moderate risk of bias suggests that adrenal biopsy appears to be most useful in the diagnosis of adrenal metastasis in patients with a history of extra-adrenal malignancy. Adrenal biopsy should only be performed if the expected findings are likely to alter the management of the individual patient and after biochemical exclusion of catecholamine-producing tumors to help prevent potentially life-threatening complications.

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Abstract 3725: Simvastatin but Not Pravastatin Affects Sleep: Findings from the UCSD Statin Study

Circulation ◽

10.1161/circ.116.suppl_16.ii_847 ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Beatrice A Golomb ◽

Edwin K Kwon ◽

Michael H Criqui ◽

Joel E Dimsdale

Keyword(s):

Sleep Quality ◽

Rating Scale ◽

Sleep Problems ◽

Small Sample Size ◽

Case Reports ◽

Controlled Trial ◽

Small Sample ◽

T Test ◽

Secondary Outcome ◽

Regression Analyses

Background : Case reports have suggested possible effects of lipophilic statins on sleep in some subjects. Most randomized studies evaluating the effect of statins on sleep have had small sample size and short duration (≤ 6 weeks). Whether statins affect sleep on average, favorably or adversely, has been unclear. Goal : To assess the effects of lipophilic and hydrophilic statins on sleep. Subjects : 1016 adult men and women without diabetes or heart disease, with LDL-cholesterol 115–190mg/dL. Design : Randomized double blind placebo-controlled trial of simvastatin 20mg, pravastatin 40mg or placebo for 6 months. Sleep was a prespecified secondary outcome. It was assessed by both an adaptation of the Leeds sleep scale (a visual analog scale of sleep quality); and a rating scale of sleep problems. Both items were measured at baseline and on-treatment. Analysis : Baseline comparability of randomization groups including sleep measures was affirmed. T-test of mean on-treatment sleep scores across randomization groups was performed. This complemented regression analyses, adjusted for baseline values of the respective sleep assessment. Results : Groups were comparable at baseline on variables including both sleep measures. Simvastatin use was associated with significantly worse sleep quality, and significantly greater reported sleep problems than either pravastatin or placebo, by t-test and regression analyses. Pravastatin did not differ significantly from placebo on any sleep outcome. Conclusion : Findings were compatible with the hypothesis that statins may impair sleep in some subjects, and that this impairment may arise selectively with lipophilic statins. Table 1. Effects of Statins on Sleep: Regression Analysis

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