scholarly journals A multicentre, randomised controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis

2021 ◽  
Author(s):  
David G. Armstrong ◽  
Dennis P. Orgill ◽  
Robert Galiano ◽  
Paul M. Glat ◽  
Lawrence Didomenico ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Interim Analysis ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled

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

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.

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

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.

Treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple-blind, placebo-controlled, clinical trial

2008 ◽  
Vol 25 (9) ◽  
pp. 1090-1095 ◽  
Author(s):  
M. Rullan ◽  
L. Cerdà ◽  
G. Frontera ◽  
L. Masmiquel ◽  
J. Llobera
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers

scholarly journals A Review of Topical Phage Therapy for Chronically Infected Wounds and Preparations for a Randomized Adaptive Clinical Trial Evaluating Topical Phage Therapy in Chronically Infected Diabetic Foot Ulcers

Antibiotics ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. 377
Author(s):  
Christopher Anthony Duplessis ◽  
Biswajit Biswas
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Chronic Wounds ◽  
Phage Therapy ◽  
Venous Stasis ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Cutaneous Wounds ◽  
Efficacious Treatment

The advent and increasing prevalence of antimicrobial resistance commensurate with the absence of novel antibiotics on the horizon raises the specter of untreatable infections. Phages have been safely administered to thousands of patients exhibiting signals of efficacy in many experiencing infections refractory to antecedent antibiotics. Topical phage therapy may represent a convenient and efficacious treatment modality for chronic refractory infected cutaneous wounds spanning all classifications including venous stasis, burn-mediated, and diabetic ulcers. We will initially provide results from a systematic literature review of topical phage therapy used clinically in refractorily infected chronic wounds. We will then segue into a synopsis of the preparations for a forthcoming phase II a randomized placebo-controlled clinical trial assessing the therapeutic efficacy exploiting adjunctive personalized phage administration, delivered topically, intravenously (IV) and via a combination of both modalities (IV + topical) in the treatment of infected diabetic foot ulcers (perhaps the canonical paradigm representing complicated recalcitrant infected cutaneous wounds).

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