Safety and Efficacy of a Novel Topical Formulation Containing Erythropoietin
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|ClinicalTrials.gov Identifier: NCT02361931|
Recruitment Status : Recruiting
First Posted : February 12, 2015
Last Update Posted : April 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Chronic Ulcers||Drug: A formula with erythropoietin Drug: Hydrogel||Phase 2|
Erythropoietin (EPO) has been shown to play a major role in wound healing. EPO is a safe molecule, and commercially available biomolecule which is the basis of an FDA approved drug for treating anemia. EPO has a known mechanism of action on chronic wounds that affects all phases of the wound healing process and has shown promising results in experimental animal wound models [Hamed et al., 2010, 2011]. In humans, topically applied EPO considerably enhanced wound healing and improved wound conditions of acute and chronic wounds [Bader et al., 2011]. Our study seeks to extend these findings, to investigate the efficacy of EPO for treatment of diabetic chronic wounds in humans.
The investigative product, developed by Remedor, is a unique gel formulation that optimizes the administration of EPO to the wound bed. This novel formulation has been shown to stabilize EPO in the gel and to maintain its activity over long periods.
The Remedor formulation used in the clinical trials will be prepared either by a compounding pharmacy which is approved by the Israeli Ministry of Health, or by an Israeli GMP certified pharmaceutical plant.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||SAFETY AND EFFICACY OF A NOVEL TOPICAL FORMULATION CONTAINING ERYTHROPOIETIN FOR THE TREATMENT OF CHRONIC DIABETIC ULCERS. A DOUBLE-BLIND RANDOMIZED PLACEBO CONTROLLED PILOT STUDY|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||March 2017|
Experimental: Treatment group (erythropoietin)
15 patients will receive erythropoietin (3000IU/ml) containing formula. Topically, five days a week for 12 weeks.
|Drug: A formula with erythropoietin|
Active Comparator: Standard Care group
5 patients will receive Hydrogel. Daily for three months.
- No Safety issues compared to Std treatment [ Time Frame: 4 months ]
The wound will be treated either with the investigational formulation or the conventional treatment daily for 3 months.. After 15 minutes, the wound will be dressed with a fresh TegadermTM dressing. Monitoring of any adverse events will be performed on a daily basis.
Once a week, the wound will be monitored by a physician: wound size will be determined and documented by photograph. Patients will be evaluated for pain sensation at the wound area and satisfaction by completing a QoL questionnaire Once a month during the experiment and one month after the end of treatment patients will undergo blood profile, blood glucose, and urine samples testing: at the initial and terminating visits. ECG and Ulcer culture will be also carried out. HbA1c, will be monitored once in 4 months
- Complete closure of the wound [ Time Frame: up to 6 months ]Same as above
- Accelerated healing (time to healing and improvement compared to baseline) [ Time Frame: 7 months ]Same as above
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361931
|Rambam Health Care Campus||Recruiting|
|Contact: Rinat Lasker +972503312506 firstname.lastname@example.org|
|Study Chair:||Yehuda Ullman, Professor||Rambam Health Care Campus|