Optimal wound closure of diabetic foot ulcers with early initiation of TLC-NOSF treatment: post-hoc analysis of Explorer

Objective: In March 2018, the Explorer study, an international, double-blind, randomised controlled trial (RCT), established that adding a TLC-NOSF (UrgoStart Contact, Laboratoires Urgo, France) dressing to good local standard of care (SoC) significantly and substantially increases wound closure and reduces the healing time of neuroischaemic diabetic foot ulcers (DFU). Besides the TLC-NOSF treatment, the wound duration was the only other covariate that had an influence on the wound closure rate in the regression model used in the original study. The purpose of this work was to further document the impact of wound duration on the healing outcomes of the DFUs included in the Explorer study and to discuss complementary pragmatic observations on the TLC-NOSF effect. Method: In this post-hoc analysis of the Explorer data, the wound closure rates by week 20 are reported for the global cohort (n=240, Intention-to-treat population) and for the treated (n=126) and control groups (n=114) according to DFU duration and location. Results: For the combined group, wound closure rates decreased with the increase of wound duration at baseline (from 57% in wounds ≤2 months to 19% in wounds >11 months). Whatever the wound duration subgroups analysed, higher closure rates were reported in the TLC-NOSF group than in the control group. However, the maximal difference between the two treatments was reported in wounds with a duration of ≤2 months (71% versus 41%, 30 percentage points difference, Relative Risk 1.7, 95% Confidence Interval 1.1 to 2.8). Regarding wound location subgroup analyses, the outcomes were always in favour of the TLC-NOSF treatment, with closure rates ranging between 43% and 61% within the TLC-NOSF group, and between 25% and 40% within the control group. Conclusion: This clinical evidence supports that treating DFUs with TLC-NOSF dressing and good SoC results in higher wound closure rates than with a neutral dressing and the same good standard of care, whatever the duration and the location of the treated wounds. However, the earlier the TLC-NOSF dressing is initiated in DFU treatment, the greater the benefits.

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A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers

Journal of Comparative Effectiveness Research ◽

10.2217/cer-2019-0142 ◽

2020 ◽

Vol 9 (1) ◽

pp. 23-34 ◽

Cited By ~ 4

Author(s):

Thomas E Serena ◽

Raphael Yaakov ◽

Sarah Moore ◽

Windy Cole ◽

Stacey Coe ◽

...

Keyword(s):

Amniotic Membrane ◽

Diabetic Foot ◽

Wound Closure ◽

Controlled Trial ◽

Standard Of Care ◽

Foot Ulcers ◽

Controlled Clinical Trial ◽

Diabetic Foot Ulcers ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled

Aim: Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16–2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion: HSAM increased frequency and probability of wound closure in DFUs versus SOC.

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Topical Erythropoietin Accelerates Wound Closure in Patients with Diabetic Foot Ulcers: A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial.

Rejuvenation Research ◽

10.1089/rej.2020.2397 ◽

2021 ◽

Author(s):

Saher Hamed ◽

Yehuda Ullmann ◽

Mark Belokopytov ◽

Aziz Shoufani ◽

Hoda Kabha ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Diabetic Foot ◽

Wound Closure ◽

Controlled Trial ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Randomized Controlled ◽

Single Blind

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Effect of a Multidomain Lifestyle Intervention on Estimated Dementia Risk

Journal of Alzheimer s Disease ◽

10.3233/jad-210331 ◽

2021 ◽

pp. 1-6

Author(s):

Alina Solomon ◽

Ron Handels ◽

Anders Wimo ◽

Riitta Antikainen ◽

Tiina Laatikainen ◽

...

Keyword(s):

Lifestyle Intervention ◽

Intervention Study ◽

Controlled Trial ◽

Control Group ◽

Post Hoc Analysis ◽

Randomized Controlled ◽

Dementia Risk ◽

Geriatric Intervention ◽

Prevention Potential ◽

Post Hoc

We investigated the effect of a multidomain lifestyle intervention on the risk of dementia estimated using the validated CAIDE risk score (post-hoc analysis). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) is a 2-year randomized controlled trial among 1,260 at-risk older adults (60–77 years). Difference in the estimated mean change in CAIDE score at 2 years in the intervention compared to the control group was –0.16 (95 %CI –0.31 to 0.00) (p = 0.013), corresponding to a relative dementia risk reduction between 6.04–6.50%. This could be interpreted as a reflection of the prevention potential of the intervention.

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Emerging Diabetic Foot Ulcer Microbiome Analysis using Cutting Edge Technologies

Journal of Diabetes Science and Technology ◽

10.1177/1932296821990097 ◽

2021 ◽

pp. 193229682199009

Author(s):

Brian M. Schmidt

Keyword(s):

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Standard Of Care ◽

Molecular Techniques ◽

Foot Ulcers ◽

Care Practice ◽

Antibiotic Administration ◽

Diabetic Foot Ulcers ◽

Conventional Culture

One of the most prevalent complications of diabetes mellitus are diabetic foot ulcers (DFU). Diabetic foot ulcers represent a complex condition placing individuals at-risk for major lower extremity amputations and are an independent predictor of patient mortality. DFU heal poorly when standard of care therapy is applied. In fact, wound healing occurs only approximately 30% within 12 weeks and only 45% regardless of time when standard of care is utilized. Similarly, diabetic foot infections occur in half of all DFU and conventional microbiologic cultures can take several days to process before a result is known. DFU represent a significant challenge in this regard because DFU often demonstrate polymicrobial growth, become resistant to preferred antibiotic therapy, and do not inform providers about long-term prognosis. In addition, conventional culture yields may be affected by the timing of antibiotic administration and collection of tissue for analysis. This may lead to suboptimal antibiotic administration or debilitating amputations. The microbiome of DFU is a new frontier to better understand the interactions between host organisms and pathogenic ones. Newer molecular techniques are readily available to assist in analyzing the constituency of the microbiome of DFU. These emerging techniques have already been used to study the microbiome of DFU and have clinical implications that may alter standard of care practice in the near future. Here emerging molecular techniques that can provide clinicians with rapid DFU-related-information and help prognosticate outcomes in this vulnerable patient population are presented.

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Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

Journal of Wound Care ◽

10.12968/jowc.2021.30.sup5.s7 ◽

2021 ◽

Vol 30 (Sup5) ◽

pp. S7-S14

Author(s):

Thomas E Serena ◽

Neal M Bullock ◽

Windy Cole ◽

John Lantis ◽

Lam Li ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Diabetic Foot ◽

Oxygen Therapy ◽

Wound Closure ◽

Foot Ulcers ◽

Controlled Clinical Trial ◽

Diabetic Foot Ulcers ◽

Open Label ◽

Number Of Patients

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

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