ENERGI-F703 GEL for Diabetic Foot Ulcers

Recruiting at27 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Energenesis Biomedical Co., Ltd.

Must be taking: Diabetes medications

Must not be taking: Corticosteroids, Immunosuppressives, Chemotherapy

Disqualifiers: Osteomyelitis, Poor nutrition, Coronary disease, others

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. ^{1 2 3 4 5}

How 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. ^{1 3 5 6 7}

Research Team

Eligibility 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 not pregnant, breastfeeding, and I am using effective birth control.

Exclusion Criteria

Enrollment in any investigational drug trial within 4 weeks before entering this study

I haven't had cancer in the past 2 years, except for certain types.

Your ankle brachial index is lower than 0.8 or higher than 1.4.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Treatment

Participants receive ENERGI-F703 GEL or vehicle control, applied topically twice daily for 16 weeks

16 weeks

Visits at Weeks 4, 6, 8, 10, 12, 14, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits at Weeks 18, 20, 24, and 28

Treatment Details

Interventions

• ENERGI-F703 GEL (Other)

Trial Overview 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).

Participant Groups

Group I: ENERGI-F703 GEL Experimental Treatment 1 Intervention

ENERGI-F703, topical application, 2 times daily for 16 weeks

Group II: ENERGI-F703 matched vehicle Placebo Group 1 Intervention

ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks

Who Is Running the Clinical Trial?

Energenesis Biomedical Co., Ltd.

Lead Sponsor

Trials

4

Recruited

520+

Findings from Research

In a randomized, double-blind, placebo-controlled trial involving 216 patients with diabetes and hard-to-heal ulcers, PDRN treatment resulted in a significantly higher complete healing rate of 37.3% compared to 18.9% in the placebo group after 8 weeks (P = .0027).

PDRN not only improved the healing rate but also reduced the median time to complete wound healing from 49 days in the placebo group to 30 days in the PDRN group, demonstrating its efficacy in accelerating the healing process for diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of PDRN, an adenosine receptor A2A agonist, on the healing of chronic diabetic foot ulcers: results of a clinical trial. Squadrito, F., Bitto, A., Altavilla, D., et al.[2022]

The Explorer study is a large, double-blind, randomized controlled trial across Europe, evaluating the efficacy and tolerability of UrgoStart Contact, a specialized dressing for diabetic foot ulcers.

This study aims to provide robust data on the treatment's effectiveness and safety, involving a significant number of patients and multiple investigating centers across various countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Explorer study: the first double-blind RCT to assess the efficacy of TLC-NOSF on DFUs. Shanahan, DR.[2016]

Autologous platelet-rich gel (APG) has been shown to significantly accelerate the healing of refractory chronic diabetic cutaneous ulcers, making it a promising treatment option.

The effectiveness of APG is likely due to the high levels of growth factors released from platelets, which play a crucial role in the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of autologous platelet-rich gel to refractory chronic diabetic cutaneous ulcers]. Yuan, N., Ran, X.[2007]

Topical adenosine A2A receptor agonists have been shown to accelerate wound closure, with ongoing clinical studies investigating their effectiveness for treating diabetic foot ulcers.

Adenosine A2A receptors enhance the functions of key cells involved in wound healing, such as inflammatory cells, endothelial cells, and fibroblasts, suggesting a beneficial mechanism of action in promoting tissue repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adenosine receptors and wound healing, revised. Cronstein, BM.[2018]

In a randomized controlled trial involving 20 patients with diabetic foot ulcers, those treated with a topical erythropoietin (EPO) hydrogel showed a significantly higher rate of 75% ulcer closure compared to those receiving standard-of-care treatment alone (60% vs. 12.5%).

The mean size of the ulcers treated with topical EPO was significantly smaller after 12 weeks, and the healing process (re-epithelialization) was faster, with no reported adverse events, indicating that topical EPO is a safe and effective option for treating diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Erythropoietin Accelerates Wound Closure in Patients with Diabetic Foot Ulcers: A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial. Hamed, S., Ullmann, Y., Belokopytov, M., et al.[2021]

This study aims to systematically review the efficacy and safety of autologous platelet-rich gel (APRG) and continuous vacuum sealing drainage (CVSD) for treating diabetic foot ulcers (DFU), analyzing various outcomes such as healing time and quality of life.

The review will include data from multiple electronic databases and assess the effectiveness of these treatments, providing valuable evidence for their use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich gel and continuous vacuum sealing drainage for the treatment of patients with diabetic foot ulcer: Study Protocol. Xu, J., Wang, QY., Li, W.[2022]

Autologous platelet-rich gel (APG) significantly improves healing rates and shortens healing time for diabetic chronic cutaneous ulcers, based on a systematic review of 15 randomized control trials involving 829 patients.

APG also reduces the incidence of infection compared to standard care, indicating it is an effective and safe adjuvant treatment for these types of ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich gel treatment for diabetic chronic cutaneous ulcers: A meta-analysis of randomized controlled trials. Li, Y., Gao, Y., Gao, Y., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of PDRN, an adenosine receptor A2A agonist, on the healing of chronic diabetic foot ulcers: results of a clinical trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The Explorer study: the first double-blind RCT to assess the efficacy of TLC-NOSF on DFUs. [2016]

3. China pubmed.ncbi.nlm.nih.gov

[Application of autologous platelet-rich gel to refractory chronic diabetic cutaneous ulcers]. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Adenosine receptors and wound healing, revised. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Topical Erythropoietin Accelerates Wound Closure in Patients with Diabetic Foot Ulcers: A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich gel and continuous vacuum sealing drainage for the treatment of patients with diabetic foot ulcer: Study Protocol. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich gel treatment for diabetic chronic cutaneous ulcers: A meta-analysis of randomized controlled trials. [2019]