A Phase 1/2 interventional study of A hydrogel containing erythropoietin and Hydrogel (as a part of SOC) in Diabetic Foot Ulcer, sponsored by Remedor Biomed Ltd. Completed at 5 sites in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Remedor Biomed Ltd · Phase 1/2, Interventional, and Treatment
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.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with Remedor Biomed Ltd as lead sponsor.
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Patients must satisfy all of the following inclusion criteria to be included in the study:
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following exclusion criteria:
10 patients receive RMD-G1 (gel with 2000 IU/ml of erythropoietin) as an adjunct therapy to standard of care (SOC). Topical application on wound bed, daily for 12 weeks.
Drug: A hydrogel containing erythropoietin
10 patients receive SOC alone daily for 12 weeks. A moisturizing gel is applied on wound bed as a part of SOC.
Drug: Hydrogel (as a part of SOC)
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.
Also known as: Standard of care (SOC)
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.
Also known as: Standard of care (SOC)
Number of participants without adverse events following RMD-G1 treatment
Absence of serious adverse events associated with the RMD-G1 treatment.
Time frame: 24 weeks
Number of participants with the reduction of wound area by 75%$ or more
Wound area will be assessed weekly for 75% closure or more of the wound area, which is defined as 75% epithelialization of the wound with no secretions.
Time frame: 12 weeks
Number of patients with hypersensitivity at the wound site.
Weekly assessments of wound site for signs of hypersensitivity to the RMD-G1 treatment.
Time frame: 12 weeks
Speed of healing
The time to reach complete wound closure (days).
Time frame: 12 weeks
Reduction of wound area
Absolute wound area regression (AWAR) (cm2) will be assessed weekly.
Time frame: 12 weeks
Partial wound closure
The number of participants with a wound surface area regression ≥ 50% and ≥ 75% by week 4.
Time frame: 4 weeks
Rate of wound closure
Mean rate of wound closure (sq. cm./day) will be assessed weekly.
Time frame: 12 weeks
Recurrence of closed wounds
Number of wound recurrence cases
Time frame: 24 weeks
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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