DermGEN™ for Diabetic Foot Ulcers

Overseen By Idevania Costa, RN, NSWOC (S), Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DeCell Technologies Inc.

Must not be taking: Immunosuppressants, Blood thinners

Disqualifiers: Active liver disease, Cancer, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a special skin graft called DermGEN™ to help heal foot ulcers in First Nations people with diabetes. The graft helps wounds heal by providing a structure that supports natural cell growth. The study aims to determine the effectiveness of this new treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressant medications or blood thinners, you may not be eligible to participate.

What data supports the effectiveness of the treatment DermGEN™ for diabetic foot ulcers?

Research on similar treatments, like DermACELL, shows that acellular dermal matrices can help heal complex diabetic foot ulcers by providing a supportive structure for skin to grow over. This suggests that DermGEN™, which is likely similar, could also be effective in treating these types of wounds. ^{1 2 3 4 5}

Is DermGEN™ safe for use in humans?

The safety of DermGEN™ (also known as DermACELL) has been evaluated in studies for diabetic foot ulcers, showing it to be safe for human use. No significant adverse effects were reported, indicating it is generally well-tolerated. ^{1 3 6 7 8}

Research Team

Paul F Gratzer, Ph.D.

Principal Investigator

Dalhousie University

Eligibility Criteria

This trial is for First Nations people with Type I or II diabetes and an active diabetic foot ulcer. Participants must be willing to wear a Total Contact Cast, have stable diabetes (HbA1C between 5.0 to 10 mmol/L), and ulcers suitable for skin grafting without deep tissue exposure. Exclusions include non-diabetes-related ulcers, certain medical conditions, immunosuppressant use, cancer not in remission for over 5 years, severe liver disease or infection, pregnancy intention during the study period, smoking habit or known allergies to specific antibiotics.

Inclusion Criteria

Participant and social support (e.g., family, caregiver) ready and willing to participate and comply with follow-up regime

I am willing to wear a Total Contact Cast for my treatment.

My diabetes is stable with HbA1C levels between 5.0 to 10 mmol/L.

Exclusion Criteria

Medical condition(s) that in the investigators' opinion make the patient inappropriate for study (e.g active liver disease)

I am currently pregnant or plan to become pregnant during the study.

My ulcer is not caused by diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DermGEN™ or standard of care for diabetic foot ulcers

20 weeks

Weekly visits for ongoing assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DermGEN™

Trial Overview The trial compares standard wound care against the application of DermGEN™ - a decellularized dermal matrix on diabetic foot ulcers among First Nations individuals. It's a randomized study where participants are equally divided into two groups: one receiving regular care and the other getting DermGEN™ treatment alongside regular care.

Participant Groups

Group I: DermGEN™ Experimental Treatment 1 Intervention

A decellularized dermal matrix created from donated human skin. This arm will receive the same care as the Standard of Care control arm-physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment-with the addition of DermGEN™ onto the wound at the first visit.

Group II: Standard of Care Active Control 1 Intervention

The standard of care includes physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment

Who Is Running the Clinical Trial?

DeCell Technologies Inc.

Lead Sponsor

Trials

1

Recruited

120+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Lakehead University

Collaborator

Trials

29

Recruited

3,900+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

In a study of 61 participants with large diabetic foot ulcers (DFUs), the acellular dermal matrix allograft DermACELL (D-ADM) achieved 100% granulation in 47 participants within an average of 4 weeks, demonstrating its efficacy in promoting wound healing.

The treatment resulted in an average wound area reduction of 80.3% over 16 weeks, with no complications reported, indicating that D-ADM is a safe option for managing complex DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Cazzell, S., Moyer, PM., Samsell, B., et al.[2020]

In a 16-week study involving 168 patients, the human acellular dermal matrix DermACELL showed a significantly higher healing rate for diabetic foot ulcers compared to conventional care (67.9% vs 48.1%).

DermACELL also demonstrated a greater average reduction in wound area compared to both conventional care and another acellular dermal matrix, Graftjacket, indicating its potential as an effective treatment option for these ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Walters, J., Cazzell, S., Pham, H., et al.[2020]

The innovative intelligent insole system significantly reduced the incidence of diabetic foot ulcers by 71% over 18 months in high-risk patients compared to a control group, demonstrating its efficacy in preventing ulcer recurrence.

In patients who complied well with the system, the reduction in ulcer incidence was even greater at 86%, highlighting the potential of continuous plantar pressure monitoring and dynamic offloading guidance in managing diabetic foot health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Abbott, CA., Chatwin, KE., Foden, P., et al.[2021]

A 56-year-old woman with a severe diabetic foot ulcer (Wagner grade 3) was successfully treated using a combination of advanced wound care techniques, including a new human acellular dermal matrix graft called DermACELL.

The treatment not only healed the ulcer but also helped save her limb and restore her ability to perform daily activities, highlighting the efficacy of DermACELL in managing complex diabetic wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DermACELL: Human Acellular Dermal Matrix Allograft A Case Report. Cole, WE.[2017]

References

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

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. [2020]

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

Early identification of delayed wound healing in complex diabetic foot ulcers treated with a dermal regeneration template: A novel clinical target and its risk factors. [2023]

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

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. [2021]

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

Use of injectable collagen to treat chronic diabetic foot ulcers. [2013]

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

DermACELL: Human Acellular Dermal Matrix Allograft A Case Report. [2017]

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

Clinical Study on the Efficacy of Silver Ion Dressing Combined with Prontosan Gel Dressing in the Treatment of Diabetic Foot Ulcers and the Effect on Serum Inflammatory Factors. [2023]

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

Treatment of nonhealing diabetic foot ulcers with a platelet-derived growth factor gene-activated matrix (GAM501): results of a phase 1/2 trial. [2022]