What side effects are associated with this type of intervention?

Common treatments for foot ulcers, including topical gels like ENERGI-F703 GEL, often cause local side effects such as redness, itching, and irritation at the application site. Allergic reactions and delayed wound healing can also occur. Severe side effects are rare but may include systemic allergic reactions or infections if the wound care is not properly managed.

What prior FDA approvals exist?

FDA-approved treatments for diabetic foot ulcers include a variety of wound care products and therapies. One notable treatment is Regranex (becaplermin) gel, which contains a recombinant human platelet-derived growth factor that promotes wound healing. Another treatment is Apligraf, a bioengineered skin substitute that combines bovine collagen with living human skin cells to aid in wound closure. Additionally, Dermagraft, a cryopreserved human fibroblast-derived dermal substitute, is used to treat diabetic foot ulcers by providing a scaffold for cell growth and tissue regeneration. These treatments focus on enhancing the body's natural healing processes and providing necessary support for wound closure.

What other types of research exist?

Promising alternatives to ENERGI-F703 GEL for foot ulcer treatment include: 1) Topical growth factors like PDGF (platelet-derived growth factor) which promote wound healing. 2) Advanced wound dressings such as those containing silver or honey, which have antimicrobial properties. 3) Stem cell therapy, which has shown potential in regenerating damaged tissues. 4) Hyperbaric oxygen therapy, which enhances oxygen supply to the wound area, promoting healing. 5) Bioengineered skin substitutes like Apligraf and Dermagraft, which provide a scaffold for new tissue growth.

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ENERGI-F703 GEL for Diabetic Foot Ulcers

Phase 3

Recruiting

Research Sponsored by Energenesis Biomedical Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diabetic foot ulcers should be free of any necrosis or infection

Subject must have at least 1 cutaneous ulcer on the foot that has not healed for at least 4 weeks, meeting specific criteria for size and classification according to Wagner Grading System

Must not have

History or evidence of osteomyelitis as confirmed by the investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects aren't listed here, typical concerns may include skin irritation at the application site or allergic reactions to ingredients in the gel. Close monitoring will identify any potential side effects during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diabetic foot ulcer does not have dead tissue or infection.

Select...

I have a foot ulcer that hasn't healed in over 4 weeks.

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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.

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I am 18 years old or older.

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I have diabetes with specific blood sugar and A1c levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a bone infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The ulcer complete closure rate

Secondary study objectives

The frequency and severity of adverse events

The proportion of subjects with complete ulcer closure

The time to ulcer closure

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetic foot ulcers work through various mechanisms to promote healing and prevent complications. Topical treatments, such as antimicrobial gels and dressings, help reduce bacterial load and prevent infection. Debridement involves the removal of dead or infected tissue, which stimulates the healing process by exposing healthy tissue. Advanced therapies, including growth factors and skin substitutes, aim to enhance tissue regeneration and repair. These mechanisms are crucial for patients as they address the underlying issues of infection, poor circulation, and impaired healing, which are common in diabetic foot ulcers, thereby improving outcomes and reducing the risk of severe complications like amputation.