ENERGI-F703 GEL for Diabetic Foot Ulcers

Recruiting at 31 trial locations

Overseen By Kellie Wallace-Wilding, Dr.

Age: 18+

Sex: Any

Trial Phase: Phase 3

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) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 22

Duration: 16 weeks

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new gel treatment, ENERGI-F703 GEL, for diabetic foot ulcers, which are open sores or wounds that do not heal easily. The study will compare the gel's effectiveness and safety against a placebo (inactive treatment) over 16 weeks. It seeks individuals with diabetes who have had at least one foot ulcer that hasn’t healed for over four weeks and is free of infection. Participants will apply the gel or placebo twice daily and will be monitored for changes in their ulcers. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that ENERGI-F703 GEL is likely to be safe for humans?

Research shows that ENERGI-F703 GEL is a safe and well-tolerated treatment for diabetic foot and leg ulcers. Earlier studies found that the gel, which contains adenine, can help heal these ulcers. These studies reported no major safety issues. People using the gel handled it well, and any side effects were mild, indicating no serious problems. While ongoing studies continue to gather more information, current evidence suggests that ENERGI-F703 GEL is generally safe to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic foot ulcers?

Unlike the standard treatments for diabetic foot ulcers, which often involve wound dressings, antibiotics, or even surgery, ENERGI-F703 GEL offers a unique approach by utilizing a topical gel applied directly to the ulcer. This gel is applied twice daily and is designed to promote healing over a 16-week period. Researchers are excited about ENERGI-F703 GEL because it may offer a more targeted and less invasive option, potentially speeding up the healing process compared to traditional methods.

What evidence suggests that ENERGI-F703 GEL might be an effective treatment for diabetic foot ulcers?

Research has shown that ENERGI-F703 GEL, which participants in this trial may receive, effectively heals diabetic foot sores. In earlier studies, patients using the gel experienced better healing for sores larger than 1.5 cm². The treatment is considered safe and easy to use. These findings suggest that ENERGI-F703 GEL can help heal diabetic foot sores, especially those with a Wagner Grade of 1 or 2. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ENERGI-F703 GEL

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00227-9/fulltext

ENERGI-F703 gel, as a new topical treatment for diabetic ... The results revealed statistically significantly greater efficacy in healing diabetic foot and leg ulcers of Grade ≤ 2 and >1.5 cm2, while ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05930210

A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot ... This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05930210/a-study-to-evaluate-energi-f703-gel-in-diabetic-foot-ulcer

A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot ... This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ...

4. researchgate.net researchgate.net/publication/361892352_ENERGI-F703_gel_as_a_new_topical_treatment_for_diabetic_foot_and_leg_ulcers_A_multicenter_randomized_double-blind_phase_II_trial

ENERGI-F703 gel, as a new topical treatment for diabetic ... The current study evaluated the safety and efficacy of ENERGI-F703 for patients with diabetic foot and leg ulcers. ... diabetic foot ulcers (DFUs) outcomes.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35844773/

ENERGI-F703 gel, as a new topical treatment for diabetic ... Our study suggests that ENERGI-F703 gel is a safe and well-tolerated treatment for chronic diabetic foot and leg ulcers.