ENERGI-F703 GEL for Diabetic Foot Ulcers
Recruiting in Palo Alto (17 mi)
+27 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Energenesis Biomedical Co., Ltd.
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial is testing a special gel called ENERGI-F703 GEL to see if it can help heal foot ulcers in people with diabetes. The study focuses on patients with mild to moderate diabetic foot ulcers. The gel works by creating a good environment for skin repair and protecting the wound from germs. ENERGI-F703 gel, containing adenine as its active ingredient, has shown promise in accelerating wound healing in diabetic mice.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you require treatment with systemic corticosteroids, immunosuppressive, or chemotherapeutic agents, you may not be eligible to participate.
What data supports the effectiveness of the drug ENERGI-F703 GEL for treating diabetic foot ulcers?
Research shows that adenosine A2A receptor agonists, like those in ENERGI-F703 GEL, help wounds heal faster by supporting the functions of cells involved in healing. Additionally, similar treatments, such as topical erythropoietin, have shown promise in promoting wound closure in diabetic foot ulcers.
12345How is ENERGI-F703 GEL different from other treatments for diabetic foot ulcers?
ENERGI-F703 GEL, also known as Adenine Gel, is unique because it contains adenine, which may play a role in promoting wound healing. Unlike other treatments like platelet-rich gel or erythropoietin, which focus on different mechanisms, ENERGI-F703 GEL's use of adenine could offer a novel approach to treating diabetic foot ulcers.
13567Eligibility Criteria
This trial is for adults with diabetes who have a foot ulcer that hasn't healed in at least 4 weeks, fitting certain size and severity criteria. They must not be pregnant or breastfeeding, use reliable birth control, and have stable blood sugar levels. People can't join if they've had recent treatments that could affect results, their wound is too wet or infected, they have poor circulation in the legs, or other health issues that make it unsafe.Inclusion Criteria
My diabetic foot ulcer does not have dead tissue or infection.
I have a foot ulcer that hasn't healed in over 4 weeks.
I am a man who is either surgically sterile, using reliable birth control, or abstaining from sex during and for 30 days after the study.
I am 18 years old or older.
I have diabetes with specific blood sugar and A1c levels.
Exclusion Criteria
I have been diagnosed with a bone infection.
Participant Groups
The study tests ENERGI-F703 GEL against a placebo gel to see which one is better at healing diabetic foot ulcers. Participants are randomly assigned to one of the two gels without knowing which one they get. The study lasts up to 31 weeks including screening, treatment phase (16 weeks), and safety follow-up (12 weeks).
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ENERGI-F703 GELExperimental Treatment1 Intervention
ENERGI-F703, topical application, 2 times daily for 16 weeks
Group II: ENERGI-F703 matched vehiclePlacebo Group1 Intervention
ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Reliant Medical ResearchMiami, FL
Alliance Research InstituteCanoga Park, CA
A and D Doctor CenterMiami, FL
Century ResearchMiami, FL
More Trial Locations
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Who is running the clinical trial?
Energenesis Biomedical Co., Ltd.Lead Sponsor
References
The effect of PDRN, an adenosine receptor A2A agonist, on the healing of chronic diabetic foot ulcers: results of a clinical trial. [2022]Foot ulcer is the principal cause of hospitalization for patients with diabetes. Polydeoxyribonucleotide (PDRN), an adenosine A2A receptor agonist, improves wound healing in diabetic mice.
The Explorer study: the first double-blind RCT to assess the efficacy of TLC-NOSF on DFUs. [2016]Urgo Medical recently announced the launch of the Explorer study, a large, Europe-wide, clinical study on the efficacy and tolerability of UrgoStart Contact, a lipidocolloid technology dressing impregnated with nano-oligosaccharide factor, in the treatment of diabetic foot ulceration. The number of patients, investigating centres and countries involved, as well as the length of treatment and patient follow-up, make this an ambitious, double-blind, randomised controlled trial.
[Application of autologous platelet-rich gel to refractory chronic diabetic cutaneous ulcers]. [2007]To review and evaluate the clinical application of autologous platelet-rich gel (APG) in refractory chronic diabetic cutaneous ulcers.
Adenosine receptors and wound healing, revised. [2018]Recent studies have demonstrated that application of topical adenosine A2A receptor agonists promotes more rapid wound closure and clinical studies are currently underway to determine the utility of topical A2A adenosine receptor agonists in the therapy of diabetic foot ulcers. The effects of adenosine A2A receptors on the cells and tissues of healing wounds have only recently been explored. Here we summarize the evidence indicating that adenosine and selective adenosine agonists, acting at A2A receptors, promote the salutary functions of inflammatory cells, endothelial cells and fibroblasts in stimulating wound healing.
Topical Erythropoietin Accelerates Wound Closure in Patients with Diabetic Foot Ulcers: A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial. [2021]The diabetic foot ulcer (DFU) is a major disabling complication of diabetes mellitus. Growing evidence suggests that topical erythropoietin (EPO) can promote wound healing. The aim of this study is to clinically assess the efficacy of a proprietary topical EPO-containing hydrogel for treating DFUs. We conducted a randomized, controlled trial in 20 patients with DFUs. After a 14-day screening period, the DFUs of 20 eligible participants who fulfilled the inclusion criteria were randomly assigned (1:1) to either a 12-week of daily treatment with topical EPO and standard-of-care (SOC) or SOC treatment alone. The DFUs were assessed weekly until week 12. The primary outcome was 75% ulcer closure or higher. After 12 weeks of treatment, 75% ulcer closure was achieved in 6 of the 10 patients whose DFUs were treated with topical EPO and in one of the 8 patients whose DFUs were treated with SOC alone. The mean area of the DFUs that were treated with topical EPO and SOC was significantly smaller than those treated with SOC alone (1.2 ± 1.4 cm2 vs. 4.2 ± 3.4 cm2; p = 0.023). Re-epithelialization was faster in the topically EPO-treated DFUs than in the SOC-treated DFUs. There were no treatment-related adverse events. We conclude that topical EPO is a promising treatment for promoting the healing of DFUs. Clinical Trial Registration number: NCT02361931.
Autologous platelet-rich gel and continuous vacuum sealing drainage for the treatment of patients with diabetic foot ulcer: Study Protocol. [2022]Research focusing on the efficacy of autologous platelet-rich gel (APRG) and continuous vacuum sealing drainage (CVSD) for diabetic foot ulcer (DFU) is increasing. Despite increasing knowledge on this theme, its results remain inconsistent. Thus, we will provide insight into the efficacy of APRG and CVSD for patients with DFU.
Autologous platelet-rich gel treatment for diabetic chronic cutaneous ulcers: A meta-analysis of randomized controlled trials. [2019]In recent years, many studies have reported that autologous platelet-rich gel (APG) is an effective adjuvant treatment for chronic cutaneous ulcers in diabetics. The aim of this study was to explore the efficacy and safety of APG for the topical treatment of diabetic chronic cutaneous ulcers.