Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers — Remede d'Or  

Diabetic Foot Ulcer Clinical Trial

Official title: Prospective, Multicenter, Single-blind, Randomized, Controlled Clinical Trial on Safety and Efficacy of a Novel Topical Formulation Containing Erythropoietin for the Treatment of Diabetic Foot Ulcers

Status Completed

Clinical Trial Summary

Remedor has developed a patented technology (RMD-G1), which comprises erythropoietin (EPO) as the active pharmaceutical ingredient (API) in a carbopol-based hydrogel with an FN matrix. RMD-G1 was designed to maintain EPO stability and activity over long periods and to optimize the administration of EPO onto the wound bed.

RMD-G1 is indicated for treating DFUs in adult patients with diabetes mellitus and aims to accelerate the healing of diabetic foot ulcers. RMD-G1 is an adjunct treatment, and not a substitute for good diabetic wound care, which includes initial debridement, wound cleansing, pressure relief, and infection control. In this trial, RMD-G1 is applied daily onto a clean wound at 0.25g per sq. cm. wound surface. After its application, the wound will be covered with a dressing in order to prevent leakage of the hydrogel and contamination of the wound area.

Clinical Trial Description

Delayed healing of a neuroischaemic diabetic foot ulcer (DFU) has been related to prolonged local inflammatory response, an unstable provisional matrix, increased degradation of the extracellular matrix, lack of growth factors and their receptors that are crucial for healing, fibroblast dysfunction, impaired neovascularization, increased oxidative stress, and cellular apoptosis in the wound bed, all of which collectively hinder re-epithelialisation and wound closure.

Erythropoietin (EPO) is an approved drug which is widely used for treating anaemia. EPO is a well-known glycoprotein hormone, which is primarily produced by the tubular cells of the kidney. EPO is widely known for regulating the red blood cell mass by stimulating differentiation and proliferation of precursor cells and hindering apoptosis of erythroid cells in the bone marrow. Millions of people have received EPO since its market approval by the US Food and Drug Administration in 1989 as a treatment of anaemia in patients with chronic kidney disease and later on as a treatment for chemotherapy-associated anaemia. There is growing evidence that both systemic administration and topical EPO application to skin wounds in animals with experimentally-induced diabetes mellitus (DM) and in patients with DM accelerates the healing of these wounds. This accelerated wound healing is mediated by EPO because it concomitantly suppresses the inflammatory response and apoptosis and stimulates angiogenesis, re-epithelialization, and collagen deposition.

Growing studies in experimental healthy and diabetic animals have demonstrated that systemic or topical treatment with EPO onto acute and chronic wounds and burns is safe and effective. Recently, the molecular mechanisms of EPO action in wound repair have been elucidated. EPO acts on all cutaneous cells that are involved in the wound healing process by promoting cellular differentiation and proliferation, exerting cytoprotective actions, and inhibiting inflammation and apoptosis due to the presence of EPO receptors in these cells [Hamed et al. 2014].

The aim of this multicenter, single-blind, randomized, controlled clinical trial is to evaluate the safety and efficacy of topical RMD-G1 treatment for DFUs. This study is an exploratory proof-of-concept study on RMD-G1 treatment for DFU. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

• NCT number: NCT02361931
• Study type: Interventional
• Source: Remedor Biomed Ltd
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 21, 2016
• Completion date: June 12, 2018