Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed 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.
    

Intervention name(s): A hydrogel containing erythropoietin; Hydrogel (as a part of SOC)
Intervention type(s): Drug; Drug
Intervention description(s): Standard of wound care, which includes initial debridement, wound cleansing, pressure relief, and infection control. RMD-G1 applied daily onto a clean wound at 0.25g per sq.cm. of wound surface. After its application, the wound is covered with a dressing in order to prevent leakage of the gel and contamination of the wound area.; Standard of wound care, which includes initial debridement, wound cleansing, pressure relief, and infection control. Hydrogel applied daily onto a clean wound at 0.25g per sq.cm. of wound surface. After its application, the wound is covered with a dressing in order to prevent leakage of the gel and contamination of the wound area.
Other intervention name(s): Standard of care (SOC); Standard of care (SOC)
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: erythropoietin; diabetic chronic wounds; wound healing; chronic wounds; topical treatment; re-epithelization; inflammation