Dataset Information

Interim Results of the Remede d'Or Study: A Multicenter, Single-Blind, Randomized, Controlled Trial to Assess the Safety and Efficacy of an Innovative Topical Formulation of Erythropoietin for Treating Diabetic Foot Ulcers.

ABSTRACT: Objective: To inform on the interim results of the Remede d'Or study, which is a prospective, multicenter, single-blind, randomized, controlled clinical study on the safety and efficacy of RMD-G1, a topical carbopol-based hydrogel with a fibronectin matrix whose active pharmaceutical ingredient is erythropoietin (EPO), for treating diabetic foot ulcers (DFU). Approach: The trial will comprise 20 patients with type 2 diabetes mellitus with neuroischemic DFUs who will be randomized into two groups: (1) a control group in which standard-of-care (SOC) will be used to treat the DFUs, and (2) a test group in which SOC and RMD-G1 will be used to treat the DFUs. On day 0, all participants will be randomized to receive either RMD-G1 and SOC treatment or SOC alone. The primary endpoint of the study is complete closure of the DFU within the 12-week study period following daily treatments and dressing changes. Results: Interim results reveal that those DFUs which were treated with RMD-G1 responded positively: there was a significant reduction in the wound areas. In contrast, the condition of those DFUs which were treated with only SOC deteriorated. Innovation: To date, no topical therapies with proven efficacy for treating DFUs exist. Topical application of EPO-based RMD-G1 in conjunction with SOC to a DFU accelerates their healing and closure. Conclusions: The interim results of this trial indicate that topical RMD-G1 is a safe adjunctive therapy to SOC, which accelerates the closure of a DFU. RMD-G1 is safe pharmaceutical because EPO has a proven safety profile.

SUBMITTER: Hamed S

PROVIDER: S-EPMC6906752 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Interim Results of the Remede d'Or Study: A Multicenter, Single-Blind, Randomized, Controlled Trial to Assess the Safety and Efficacy of an Innovative Topical Formulation of Erythropoietin for Treating Diabetic Foot Ulcers.

Hamed Saher S Belokopytov Mark M Ullmann Yehuda Y Safadi Muhammad M Stark Yafit Y Shoufani Aziz A Akita Sadanori S Liu Paul Y PY Teot Luc L

Advances in wound care 20190821 10

<b>Objective:</b> To inform on the interim results of the Remede d'Or study, which is a prospective, multicenter, single-blind, randomized, controlled clinical study on the safety and efficacy of RMD-G1, a topical carbopol-based hydrogel with a fibronectin matrix whose active pharmaceutical ingredient is erythropoietin (EPO), for treating diabetic foot ulcers (DFU). <b>Approach:</b> The trial will comprise 20 patients with type 2 diabetes mellitus with neuroischemic DFUs who will be randomized i ...[more]

PMID: 31832270

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Project description:BackgroundIt has been reported that ozone therapy might be helpful in treating foot ulcers in people with diabetes mellitus (DM).ObjectivesTo assess the effects of ozone therapy on the healing of foot ulcers in people with DM.Search methodsIn March 2015 we searched: The Cochrane Wounds Group Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid EMBASE, EBSCO CINAHL, Science Citation Index, Chinese Biomedical Literature Database and The Chinese Clinical Registry. There were no restrictions based on language, date or study setting.Selection criteriaWe included randomised controlled trials (RCTs) that compared ozone therapy with sham ozone therapy or any other interventions for foot ulcers in people with DM, irrespective of publication date or language.Data collection and analysisTwo reviewers independently screened all retrieved citations, selected relevant citations and extracted data. Disagreements were resolved by discussion with a third reviewer. The methodological quality of included studies and the evidence level of outcomes were assessed using the Cochrane risk of bias tool and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach respectively. Data were expressed using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes with their 95% confidence interval (95% CI). Review Manager (RevMan) software was used to analyse the data.Main resultsThree studies (212 participants) were included in this review. The overall risk of bias was high for two trials and unclear for one.One trial (101 participants) compared ozone treatment with antibiotics for foot ulcers in people with DM. The study had a follow-up period of 20 days. This study showed that ozone treatment was associated with a greater reduction in ulcer area from baseline to the end of the study than treatment with antibiotics (MD -20.54 cm(2), 95% CI -20.61 to -20.47), and a shorter duration of hospitalisation (MD -8.00 days, 95% CI -14.17 to -1.83), but did not appear to affect the number of ulcers healed over 20 days (RR 1.10, 95% CI 0.87 to 1.40). No side effects were observed in either group.The other two trials (111 participants) compared ozone treatment plus usual care with usual care for foot ulcers in people with DM. The meta-analysis results did not show evidence of a difference between groups for the outcomes of reduction of ulcer area (MD -2.11 cm(2), 95% CI -5.29 to 1.07), the number of ulcers healed (RR 1.69, 95% CI 0.90 to 3.17), adverse events (RR 2.27, 95% CI 0.48 to 10.79), or amputation rate (RR 2.73, 95%CI 0.12, 64.42).Authors' conclusionsThe available evidence was three small RCTs with unclear methodology, so we are unable to draw any firm conclusions regarding the effectiveness of ozone therapy for foot ulcers in people with DM.

Project description:BackgroundDiabetic foot and leg ulcers are a major cause of disability among patients with diabetes mellitus. A topical gel called ENERGI-F703, applied twice daily and with adenine as its active pharmaceutical ingredient, accelerated wound healing in diabetic mice. The current study evaluated the safety and efficacy of ENERGI-F703 for patients with diabetic foot and leg ulcers.MethodsThis randomized, double-blind, multicenter, phase II trial recruited patients from eight medical centers in Taiwan. Patients with intractable diabetic foot and leg ulcers (Wagner Grade 1-3 without active osteomyelitis) were randomly assigned (2:1) to receive topical ENERGI-F703 gel or vehicle gel twice daily for 12 weeks or until complete ulcer closure. The investigator, enrolled patients and site personnel were masked to treatment allocation. Intention to treat (ITT) population and safety population were patient to primary analyses and safety analyses, respectively. Primary outcome was complete ulcer closure rate at the end of treatment. This trial is registered with ClinicalTrials.gov, number NCT02672436.FindingsStarting from March 15th, 2017 to December 26th, 2019, 141 patients were enrolled as safety population and randomized into ENERGI-F703 gel (n = 95) group or vehicle gel (n = 46) group. In ITT population, ENERGI-F703 (n = 90) and vehicle group showed ulcer closure rates of 36.7% (95% CI = 26.75% - 47.49%) and 26.2% (95% CI = 13.86% - 42.04%) with difference of 9.74 % (95 % CI = -6.74% - 26.23%) and 25% quartiles of the time to complete ulcer closure of 69 days and 84 days, respectively. There were 25 (26.3%) patients in ENERGI-F703 group and 11 (23.9%) patients in vehicle group experiencing serious adverse events and five deaths occurred during the study period, none of them related to the treatment.InterpretationOur study suggests that ENERGI-F703 gel is a safe and well-tolerated treatment for chronic diabetic foot and leg ulcers. Further studies are needed to corroborate our findings in light of limitations.FundingEnergenesis Biomedical Co., Ltd.

Dataset Information

Interim Results of the Remede d'Or Study: A Multicenter, Single-Blind, Randomized, Controlled Trial to Assess the Safety and Efficacy of an Innovative Topical Formulation of Erythropoietin for Treating Diabetic Foot Ulcers.

Publications

Interim Results of the Remede d'Or Study: A Multicenter, Single-Blind, Randomized, Controlled Trial to Assess the Safety and Efficacy of an Innovative Topical Formulation of Erythropoietin for Treating Diabetic Foot Ulcers.

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