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.

Efficacy of erythropoietin for wound healing: A systematic review of the literature

“…Included studies were published between 2004 and 2019 and emanated from five different countries, including Canada [ 26 ], England [ 27 ], Iran [ 28 ], Israel [ 29 ], and Germany [ [30] , [31] , [32] ]. With regard to the study design, three of included studies were case series [ 26 , 27 , 30 ] and four studies were RCTs [ 28 , 29 , 31 , 32 ].…”

“…RCTs involved a total of 129 patients with various types of wounds, including diabetic ulcers [ 29 , 32 ], post-traumatic wounds [ 28 ], and burn and scalding injuries [ 31 ]. Three of the trials were placebo-controlled [ 28 , 31 , 32 ], and one study [ 29 ] used the standard treatment protocol for the control group of patients. Two trials were double-blind, whereas triple- [ 28 ] and single-blinding [ 29 ] were each adopted in a single trial.…”

“…Three of the trials were placebo-controlled [ 28 , 31 , 32 ], and one study [ 29 ] used the standard treatment protocol for the control group of patients. Two trials were double-blind, whereas triple- [ 28 ] and single-blinding [ 29 ] were each adopted in a single trial. All included trials suggest that application of erythrolein enhances the wound healing process.…”

“…On the Quality Assessment Tool for Case Series Studies, one study was rated as weak [ 26 ], one as moderate [ 30 ], and one as strong [ 27 ]. On the Cochrane Collaboration Risk of Bias Assessment Tool for randomized-controlled trials, two studies were rated as demonstrating a high risk of detection [ 29 ] and attrition [ 31 ] biases each. The risk of bias assessment is presented in supplementary file 3.…”

“…Based on the findings of this review, erythropoietin can be used for the treatment of both acute [ 28 , 31 ] and chronic [ 26 , 27 , 29 , 30 , 32 ] wounds. In the case of acute wounds, erythropoietin administration has the potential to not only decrease wound healing time but to prevent wounds from becoming chronic [ 36 ].…”