ProgenaMatrix for Diabetic Foot Ulcers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ProgenaCare Global, LLC

Must not be taking: Steroids, Immunosuppressants, Antibiotics, others

Disqualifiers: Gangrene, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the healing time of diabetic foot ulcers treated with ProgenaMatrix™, a new wound dressing. Individuals with type I or type II diabetes who have had a foot ulcer for 4 weeks to 12 months may qualify. The trial aims to assess the effectiveness of this treatment in closing ulcers compared to standard methods. Participants will apply ProgenaMatrix daily for 12 weeks and attend regular check-ups. This trial suits those with a single foot ulcer of manageable size who are willing to adhere to the treatment plan. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

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 steroid therapy, immunosuppressive or autoimmune therapy, or radiation therapy of the foot, you may not be eligible to participate.

What prior data suggests that ProgenaMatrix™ is safe for treating diabetic foot ulcers?

Research shows that ProgenaMatrix™ has received FDA approval for treating diabetic foot ulcers, indicating its safety for people. Additionally, studies on similar products, such as the Integra Flowable Wound Matrix, found no harmful effects in patients with diabetic foot ulcers. This offers reassurance for those considering ProgenaMatrix. Although this does not guarantee safety, the lack of reported negative effects so far is encouraging for participants considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for diabetic foot ulcers, which often involve dressings, wound care, and sometimes antibiotics, ProgenaMatrix™ offers a new approach by focusing on daily application for enhanced healing. Researchers are excited about ProgenaMatrix™ because it uses an innovative matrix technology designed to create an optimal environment for tissue regeneration and repair. This unique mechanism aims to accelerate the healing process, potentially reducing the risk of complications and improving outcomes for patients.

What evidence suggests that ProgenaMatrix™ might be an effective treatment for diabetic foot ulcers?

Research has shown that ProgenaMatrix™ can help treat diabetic foot ulcers (DFUs). In a study comparing ProgenaMatrix to standard care, patients healed faster and more effectively. Another trial found that similar treatments, such as MatriStem MicroMatrix, also produced good results for non-healing DFUs. These treatments use a special material to promote new skin growth over the ulcer. While researchers continue to gather more information, early results suggest that ProgenaMatrix may close ulcers more quickly than traditional methods. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with diabetic foot ulcers. Participants should be adults who meet specific health criteria and have a wound that's been present for at least 4 weeks but not more than a year.

Inclusion Criteria

I agree to use ProgenaMatrix™ as part of my treatment.

Have participated in the informed consent process and signed a data collection and treatment specific informed consent

Be able and willing to comply with the data collection procedures, data collection visits, dressings, and off-loading

Exclusion Criteria

I have a history of certain diseases or treatments within a specific timeframe.

I cannot walk safely even with support.

The patient has a known sensitivity to the suggested dressings

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily application of ProgenaMatrix for diabetic foot ulcers

12 weeks

Weekly updates with pre and post debridement measurements

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ProgenaMatrix™

Trial Overview The study is testing the effectiveness of ProgenaMatrix™, a keratin graft, in healing diabetic foot ulcers compared to standard care alone. It will measure how quickly the wounds close when treated with this new method.

How Is the Trial Designed?

Group I: Treatment with ProgenaMatrix Experimental Treatment 2 Interventions

application of ProgenaMatrix daily for 12 weeks

Who Is Running the Clinical Trial?

ProgenaCare Global, LLC

Lead Sponsor

Trials

2

Recruited

130+

Published Research Related to This Trial

In a multicenter study involving 95 subjects, MatriStem MicroMatrix and MatriStem Wound Matrix demonstrated similar healing outcomes for non-healing diabetic foot ulcers compared to Dermagraft, with no significant differences in wound healing rates or complete closure between the two treatments.

Patients treated with MatriStem showed significant improvements in quality of life and lower treatment costs, suggesting that while the healing efficacy is comparable, MatriStem may offer economic and patient-centered advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: an interim analysis. Frykberg, RG., Cazzell, SM., Arroyo-Rivera, J., et al.[2018]

In a study of 60 patients with diabetic foot ulcers, the Integra Flowable Wound Matrix led to a significantly higher complete healing rate of 86.95% compared to 52.17% for the wet dressing, demonstrating its efficacy in treating these complex wounds.

The use of the Integra Flowable Wound Matrix was associated with lower rates of amputation and rehospitalization compared to the control group, highlighting its safety and effectiveness in managing diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial. Campitiello, F., Mancone, M., Della Corte, A., et al.[2022]

The E-Matrix, a novel injectable scaffolding matrix derived from porcine collagen, shows promise in accelerating wound healing for diabetic foot ulcers, mimicking fetal tissue repair mechanisms.

In a pilot study involving six patients, the E-Matrix led to an impressive average wound size reduction of 72% within just 2 weeks after injection, indicating its potential efficacy in treating chronic nonhealing wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial report of the use of an injectable porcine collagen-derived matrix to stimulate healing of diabetic foot wounds in humans. Marston, WA., Usala, A., Hill, RS., et al.[2016]

In a randomized controlled trial involving 40 participants, the resorbable glass microfiber matrix (BBGFM) significantly improved healing rates of diabetic foot ulcers (DFUs) at 12 weeks, with 70% of wounds healed compared to only 25% in the standard of care group.

The BBGFM group also showed a greater reduction in wound area (79% vs. 37%) and improved neuropathic scores, indicating better overall outcomes without any adverse events related to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers. Armstrong, DG., Orgill, DP., Galiano, RD., et al.[2022]

A 57-year-old woman with a 20-day diabetic foot ulcer (DFU) showed significant healing after treatment with placenta-derived mesenchymal stem cells (PDMSCs) hydrogel, indicating its potential efficacy in wound repair.

The treatment was safe, with no complications or recurrence of the ulcer observed over a 6-month follow-up period, suggesting that PDMSCs hydrogel could be a promising new approach for managing DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-week topical treatment with placenta-derived mesenchymal stem cells hydrogel in a patient with diabetic foot ulcer: A case report. Zeng, X., Tang, Y., Hu, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06292026

Efficacy of ProgenaMatrix™ in the Management of DFUs This is a multicenter data collection and treatment study with weekly updates to include pre and post debridement measurements of wound area, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381183/

A multicentre clinical trial evaluating the outcomes of two ... Use of a purified reconstituted bilayer matrix in the management of chronic diabetic foot ulcers improves patient outcomes vs standard of care:results of a ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05797285/evaluating-the-efficacy-of-a-keratin-graft-in-treating-non-healing-diabetic-foot-ulcers

Evaluating The Efficacy Of A Keratin Graft In Treating Non ... In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either ...

4. withpower.com withpower.com/trial/phase-foot-ulcer-2-2022-53545

ProgenaMatrix for Diabetic Foot Ulcers · Info for Participants In a multicenter study involving 95 subjects, MatriStem MicroMatrix and MatriStem Wound Matrix demonstrated similar healing outcomes for non-healing diabetic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05797285

Evaluating The Efficacy Of A Keratin Graft In Treating Non ... In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10877811/

Effectiveness and safety of dermal matrix used for diabetic foot ... In this study, we performed a systematic review and meta-analysis based on high-level evidence from RCTs, and found that application of dermal ...

7. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39870&ver=4

Skin Substitute Grafts/Cellular and Tissue-Based Products ... This LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) in ...

8. ctv.veeva.com ctv.veeva.com/study/efficacy-of-progenamatrix-in-the-management-of-dfus

Efficacy of ProgenaMatrix™ in the Management of DFUs ProgenaMatrix™ is US Food and Drug Administration (FDA) cleared for the treatment of diabetic foot ulcers. The standard of care for diabetic ...