E-GRAFT + FIBRACOL for Foot Ulcer

Overseen By Adam Isaac, DPM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Skye Biologics Holdings, LLC

Must not be taking: Immunosuppressants, Chemotherapy, Steroids

Disqualifiers: Infection, Osteomyelitis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

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 are on immunosuppressants or high doses of corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment E-GRAFT ™ and FIBRACOL™ for foot ulcers?

Research shows that treatments like epidermal growth factor (EGF) can help heal diabetic foot ulcers by promoting skin repair. Additionally, other types of skin grafts, such as acellular fish skin grafts, have been effective in healing foot ulcers, suggesting that similar treatments might also be beneficial. ^{1 2 3 4 5}

Is E-GRAFT + FIBRACOL safe for treating foot ulcers?

The safety of a similar treatment, Heberprot-P, for diabetic foot ulcers was studied, and it was generally safe with some side effects like tremors, chills, pain, and local infection. This suggests that treatments like E-GRAFT + FIBRACOL might also be safe, but specific safety data for E-GRAFT + FIBRACOL is not available. ^{2 4 6 7 8}

What is the purpose of this trial?

The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Changes in neuropathy (nerve damage) * Change in pain levels * Occurrence of infection

Research Team

Charles M Zelen, DPM FACFAS

Principal Investigator

Professional Education and Research Institute

Eligibility Criteria

This trial is for adults over 18 with type 1 or 2 diabetes who have had a non-healing foot ulcer for 4-52 weeks. The ulcer must be on the foot, not probe to bone, and measure between 1.0 cm² and 10.0 cm² after debridement. Participants need adequate blood flow to the foot and must commit to weekly visits and prescribed off-loading methods.

Inclusion Criteria

My ulcer has been present for 1 to 12 months before my first screening visit.

The subject must agree to attend the weekly study visits required by the protocol

The subject must be willing and able to participate in the informed consent process

Exclusion Criteria

Women who are pregnant or considering becoming pregnant within the next 6 months are excluded

A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded

I haven't used steroid creams on the ulcer in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either E-GRAFT™ or FIBRACOL™ as the primary dressing along with standard of care for diabetic foot ulcers

12 weeks

Weekly visits for assessment and dressing changes

Follow-up

Participants are monitored for safety, effectiveness, and any adverse events after treatment

4 weeks

Treatment Details

Interventions

• E-GRAFT ™
• FIBRACOL™

Trial Overview The study compares E-GRAFT™ combined with Standard of Care (SOC) against FIBRACOL™ plus SOC in healing diabetic foot ulcers. It will assess wound closure rate, change in ulcer size over time, side effects, nerve damage changes, pain levels, and infection rates.

Participant Groups

Group I: SOC primary dressing with E-GRAFT ™ Experimental Treatment 1 Intervention

Participants receive standard of care with E-GRAFT™

Group II: SOC primary dressing with FIBRACOL™ Active Control 1 Intervention

Participants receive standard of care with FIBRACOL™

Who Is Running the Clinical Trial?

Skye Biologics Holdings, LLC

Lead Sponsor

Trials

4

Recruited

540+

Findings from Research

In a study of 36 patients with skin defects of the foot and ankle, both lateral supramalleolar flaps and reverse sural neurocutaneous flaps were effective in repairing skin defects, achieving similar therapeutic results and patient satisfaction.

The reverse sural neurocutaneous flap showed a higher success rate with 21 out of 22 flaps surviving completely, making it more suitable for larger skin defects, while the lateral supramalleolar flap is better for smaller defects around the malleolus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison between two different repairing methods for skin defects of foot and ankle]. Gong, X., Lu, L., Li, L.[2007]

In a study of 22 patients with hard-to-heal vascular leg ulcers, the advanced flowable wound matrix (FWM) treatment was well tolerated and resulted in a high healing rate, with 85% of ulcers healing within 12 weeks.

FWM treatment also significantly reduced the need for amputations compared to standard wound care, indicating its effectiveness in managing complex wound cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a flowable wound matrix to treat lower limb vascular ulcers. Florio, A., Sallustro, M.[2022]

Human recombinant epidermal growth factor (EGF) can significantly enhance healing in diabetic foot ulcers when used alongside standard treatments, potentially preventing amputations.

While intralesional injection of EGF provides better delivery to deeper wound layers, it can cause pain at the injection site, and further research is needed to determine optimal dosages, administration methods, and the types of ulcers that respond best.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidermal growth factor in the treatment of diabetic foot ulcers: an update. Tiaka, EK., Papanas, N., Manolakis, AC., et al.[2012]

In a study of 15 patients with diabetic foot ulcers, the novel autologous epidermal grafting (AEG) system demonstrated effective wound healing, with a mean healing time of 5.9 weeks.

The AEG system was found to be safe and did not show significant differences in healing times based on patient demographics or ASA scores, suggesting it can be reliably used in diabetic foot ulcer emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of autologous epidermal grafts for diabetic foot ulcer emergencies: A clinical study. Saydam, M., Yılmaz, KB., Bostancı, MT., et al.[2023]

In a study of 51 patients with diabetic foot ulcers, the use of acellular fish skin grafts resulted in an impressive 87.57% reduction in wound surface area over 16 weeks, with 60.34% of wounds fully healed.

The findings support previous research indicating that acellular fish skin grafts can effectively promote wound healing by facilitating the transition from chronic to acute healing stages, particularly showing rapid improvement in the first 4 weeks after application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular Fish Skin Graft Use for Diabetic Lower Extremity Wound Healing: A Retrospective Study of 58 Ulcerations and a Literature Review. Michael, S., Winters, C., Khan, M.[2020]

In a study involving 208 patients with chronic diabetic foot ulcers, Graftskin treatment led to a significantly higher complete healing rate (56%) compared to saline-moistened gauze (38%) after 12 weeks, indicating its effectiveness as a treatment option.

Graftskin also resulted in a faster healing time, with a median of 65 days to complete closure compared to 90 days for the control group, and had a similar safety profile, showing fewer cases of osteomyelitis and lower-limb amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Veves, A., Falanga, V., Armstrong, DG., et al.[2022]

In a pilot study involving 20 diabetic patients with chronic foot ulcers, the administration of Heberprot-P led to full granulation of wounds in all patients within an average of 23.6 days, demonstrating its efficacy in promoting healing.

Complete wound closure was achieved in 85% of cases within approximately 44 days, with no amputations required, indicating that Heberprot-P is a safe and effective treatment for high-grade diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intralesional administration of epidermal growth factor-based formulation (Heberprot-P) in chronic diabetic foot ulcer: treatment up to complete wound closure. Fernández-Montequín, JI., Betancourt, BY., Leyva-Gonzalez, G., et al.[2021]

In a study involving 30 patients with chronic venous leg ulcers, the silver-containing dressing Physiotulle-Ag led to a significant reduction in ulcer area by 55% over four weeks, indicating its efficacy in promoting healing.

The dressing was found to be safe, with no adverse events reported, and it improved the condition of the wounds by increasing healthy tissue and reducing malodor, while also being easy to apply and remove.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a new silver dressing on chronic venous leg ulcers with signs of critical colonisation. Jørgensen, B., Bech-Thomsen, N., Grenov, B., et al.[2009]

References

1. China pubmed.ncbi.nlm.nih.gov

[Comparison between two different repairing methods for skin defects of foot and ankle]. [2007]

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

Use of a flowable wound matrix to treat lower limb vascular ulcers. [2022]

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

Epidermal growth factor in the treatment of diabetic foot ulcers: an update. [2012]

4. Turkey pubmed.ncbi.nlm.nih.gov

The use of autologous epidermal grafts for diabetic foot ulcer emergencies: A clinical study. [2023]

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

Acellular Fish Skin Graft Use for Diabetic Lower Extremity Wound Healing: A Retrospective Study of 58 Ulcerations and a Literature Review. [2020]

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

Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Intralesional administration of epidermal growth factor-based formulation (Heberprot-P) in chronic diabetic foot ulcer: treatment up to complete wound closure. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effect of a new silver dressing on chronic venous leg ulcers with signs of critical colonisation. [2009]