What side effects are associated with this type of intervention?

Common side effects of treatments for foot ulcers that provide a scaffold for tissue regeneration, such as decellularized dermal matrices, include infection at the application site, allergic reactions, delayed wound healing, discomfort or pain at the treatment site, and potential issues with graft rejection or failure to integrate properly with the surrounding tissue.

What prior FDA approvals exist?

FDA-approved treatments for foot ulcers that are similar to DermGEN™ include various types of skin substitutes and scaffolds designed to promote tissue regeneration. One notable example is Apligraf, a bioengineered skin substitute composed of bovine collagen and living human cells, which has been approved for the treatment of diabetic foot ulcers. Another example is Dermagraft, a cryopreserved human fibroblast-derived dermal substitute. These treatments, like DermGEN™, provide a scaffold that supports the body's natural healing processes by promoting cell growth and tissue regeneration.

What other types of research exist?

Promising alternatives to DermGEN™ for foot ulcer treatment include ACELAGRAFT™, a decellularized and dehydrated human amniotic membrane product, which has shown potential in wound healing. Additionally, stem cell therapies, such as treatments using allogenic mesenchymal stem cells (MSCs), have demonstrated efficacy in promoting wound healing and reducing blister formation. These alternatives provide advanced options for tissue regeneration and wound management.

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Decellularized Dermal Matrix

DermGEN™ for Diabetic Foot Ulcers

N/A

Waitlist Available

Led By Paul F Gratzer, Ph.D.

Research Sponsored by DeCell Technologies Inc.

Eligibility Criteria Checklist

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

Must have

Participant willing to wear Total Contact Cast (TCC) for wound off-loading during treatment

Documented stable Type I or II diabetes (HbA1C between 5.0 to 10 mmol/L within 1 month prior to Day 0)

Must not have

Female individuals are pregnant at time or intend to get pregnant during study time

Ulcer is not classified as diabetes-related

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to and including 20 weeks post initial treatment (day 0)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions at the site of application such as redness or irritation from DermGEN™ treatment; however these would typically be monitored closely by healthcare providers.

Eligibility Criteria

Inclusion Criteria

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

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

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

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My ulcer reaches into the layer beneath my skin but does not expose muscle or bone.

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My ulcer is clean, infection-free, and ready for a skin graft.

Exclusion Criteria

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

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

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My ulcer is not caused by diabetes.

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I am currently on or might need immunosuppressant medication.

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My cancer has not been in remission for 5+ years.

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I have liver disease, hepatitis, anemia, low albumin, or high alkaline phosphatase/LDH levels.

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I have an untreated infection or an autoimmune disorder affecting my tissues.

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I am currently receiving chemotherapy or radiation therapy.

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I am able to understand and consent to participate in this study.

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My ulcer has deep tracks that cannot be fully cleaned out.

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I received radiation therapy within the last 30 days.

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I have signs of a serious skin or bone infection.

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I have an ulcer over a foot and ankle deformity due to diabetes.

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I have a bleeding disorder or am on blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to and including 20 weeks post initial treatment (day 0)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to and including 20 weeks post initial treatment (day 0)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to and including 20 weeks post initial treatment (day 0) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Impact of Treatment on Quality of Life (WoundQoL)

Impact of Treatment on Wound - LUMT Score

Incidence of adverse events.

+3 more

Secondary study objectives

Mean and median reduction in wound area at 12 weeks

Mean and median reduction in wound area at 8 weeks

Proportion with complete healing at any time point

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DermGEN™Experimental Treatment1 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 CareActive Control1 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

0 / 17Eligibility 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 foot ulcers, such as decellularized dermal matrices like DermGEN™, work by providing a scaffold for tissue regeneration. These scaffolds support the body's natural healing processes by offering a structure for cells to adhere to, which promotes the growth of new tissue and blood vessels. This mechanism is vital for foot ulcer patients as it accelerates wound healing, reduces the risk of infection, and improves overall treatment outcomes.