Antimicrobial Peptide Therapy for Diabetic Foot Ulcers

(RENEW Trial)

Overseen By Bennett Sarver

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sequence LifeScience, Inc.

Must not be taking: Immunosuppressants, Chemotherapy, Biologics

Disqualifiers: Infected ulcer, Osteomyelitis, Pregnancy, Dialysis, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of different antimicrobial peptide treatments in healing diabetic foot ulcers unresponsive to standard care. Participants will be divided into groups to test several treatments, such as Activate™ Matrix and AmnioDefend™ FT Matrix, alongside standard care. Individuals with type 1 or type 2 diabetes and a foot ulcer that hasn't healed for at least four weeks may qualify for this study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants a chance to benefit from established therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressants, certain chemotherapy drugs, or high doses of corticosteroids. It's best to discuss your specific medications with the trial team.

What is the safety track record for these treatments?

Research shows that treatments using skin-like materials, such as those in this trial, are generally safe for people with diabetic foot ulcers. Studies indicate these materials help ulcers heal faster when combined with standard care. The treatments in this trial include Activate™ Matrix, AmnioDefend™ FT Matrix, Enclose™ TL Matrix, Palisade™ DM Matrix, Sentry™ SL Matrix, and Shelter™ DM Matrix.

Many studies have confirmed the safety of these materials. Research shows they are well-tolerated and usually do not cause serious side effects. Patients using these treatments have experienced improvements without major adverse events.

Since this trial is in a later phase, substantial safety data is already available. This suggests the treatments are considered safe enough for testing in large groups. Prospective participants should find this information reassuring regarding the safety of these options. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study's treatments?

Researchers are excited about these treatments for diabetic foot ulcers because they leverage antimicrobial peptides integrated into various matrix structures. Unlike traditional standard care options that may focus more on wound cleaning and basic dressing changes, these treatments use advanced biological layers, such as amnion and chorion, to promote healing. For example, the Enclose™ TL Matrix combines three layers of amnion and chorion to potentially enhance wound recovery. Palisade™ DM Matrix offers a two-layer structure focusing on these same biological components, while Sentry™ SL Matrix simplifies the approach with a single-layer amnion. These innovative matrices aim to accelerate healing by providing a more supportive environment at the cellular level, offering hope for more effective management of diabetic foot ulcers.

What evidence suggests that this trial's treatments could be effective for diabetic foot ulcers?

This trial will evaluate various antimicrobial peptide therapies for diabetic foot ulcers. Studies have shown that different types of wound coverings can aid in healing diabetic foot ulcers. Participants in this trial may receive one of the following treatments:

- The Activate™ Matrix, which research indicates can speed up healing, with one study showing a 96% reduction in wound size over 12 weeks.

- The AmnioDefend™ FT Matrix, which has improved healing rates when used with standard care.

- The Enclose™ TL Matrix, effective in some cases, with reports of over 90% reduction in wound area after just a few treatments.

- The Palisade™ DM Matrix, noted for improving healing outcomes for long-lasting wounds.

- The Sentry™ SL Matrix, though less conclusive, is suggested to aid in wound healing.

- The Shelter™ DM Matrix, which has shown effectiveness in healing chronic diabetic foot ulcers, providing a clear benefit when added to standard care.

Overall, these treatments offer promising options for better healing of diabetic foot ulcers. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with nonhealing diabetic foot ulcers. Participants should have a specific type of chronic ulcer that hasn't improved with standard care. Details on who can join are not fully provided, but typically, participants must meet certain health criteria and be able to comply with study requirements.

Inclusion Criteria

I have been diagnosed with type 1 or type 2 diabetes.

If I have multiple ulcers, the largest one will be the main focus of treatment.

Subject must agree to attend weekly study visits

Exclusion Criteria

Subject has a life expectancy of less than 6 months

My ulcer exposes tendon or bone.

My wound is complicated by a bone infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple CAMPs plus SOC for nonhealing diabetic foot ulcers

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Activate™ Matrix
• AmnioDefend™ FT Matrix
• Enclose™ TL Matrix
• Palisade™ DM Matrix
• Sentry™ SL Matrix
• Shelter™ DM Matrix

Trial Overview The trial tests the effectiveness of various CAMPs (cellular and/or acellular matrix products) plus standard care (SOC) in healing diabetic foot ulcers over 12 weeks. It's a randomized study comparing these treatments against matched controls using a modified platform design.

How Is the Trial Designed?

Group I: Shelter™ DM Matrix +SOC Experimental Treatment 1 Intervention

Two layers: amnion and chorion

Group II: Sentry™ SL Matrix +SOC Experimental Treatment 1 Intervention

One layer: amnion

Group III: Palisade™ DM Matrix +SOC Experimental Treatment 1 Intervention

Two layers: amnion and chorion

Group IV: Enclose™ TL Matrix +SOC Experimental Treatment 1 Intervention

Three layers: amnion, chorion, amnion

Group V: AmnioDefend™ FT Matrix +SOC Experimental Treatment 1 Intervention

Three layers: amnion, intermediate layer, and chorion

Group VI: Activate™ Matrix +SOC Experimental Treatment 1 Intervention

Three layers: amnion, intermediate layer, and chorion

Who Is Running the Clinical Trial?

Sequence LifeScience, Inc.

Lead Sponsor

Serena Group

Collaborator

Trials

6

Recruited

790+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1743919117301309

Efficacy and safety of acellular dermal matrix in diabetic ... Compared with standard of care, acellular dermal matrix may accelerate the healing velocity of uninfected, non-ischemic, full-thickness diabetic foot ulcer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8267704/

Acellular Dermal Matrix Used in Diabetic Foot Ulcers In this research report, the clinical results indicated decreased postoperative wound infection levels and a short healing time, with a sound ...

3. fastracjournal.org fastracjournal.org/article/S2667-3967(21)00136-1/fulltext

Evaluation of wound healing of diabetic foot ulcers in a ... The average reduction in wound surface area over 12 weeks was 96% ± 10%. For the wounds that healed, the average time to complete wound closure ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iwj.14018

A long‐term follow‐up study of diabetic foot ulcer using ... The rate of success of complete healing was 62.96% and the time of complete healing was 86.96 days in this study. The recurrence rate of DFUs ...

5. jvsvi.org jvsvi.org/article/S2949-9127(25)00032-7/fulltext

Meta-analysis of cellular and acellular tissue-based ... Meta-analysis of cellular and acellular tissue-based products demonstrates improvement of diabetic foot ulcer healing despite age and wound size · and Barbara ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01686139

Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers Ratios of activated matrix metalloproteinase-9 to tissue inhibitor of matrix metalloproteinase-1 in wound fluids are inversely correlated with healing of ...

7. bmcendocrdisord.biomedcentral.com bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-024-01550-3

Effectiveness and safety of dermal matrix used for diabetic foot ... Many studies have demonstrated that these dermal matrices are effective when applied as adjuvant treatment to enhance DFUs healing [17,18,19].

8. nvisionbiomed.com nvisionbiomed.com/sequence-lifescience-inc-receives-irb-approval-for-a-novel-matched-controls-clinical-trial-targeting-diabetic-foot-ulcers-dfus/

Sequence LifeScience, Inc Receives IRB Approval for a ... Sequence LifeScience, Inc Receives IRB Approval for a Novel Matched Controls Clinical Trial Targeting Diabetic Foot Ulcers (DFUs).