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

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

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

Research on similar treatments, like the Integra Flowable Wound Matrix, shows promising results in healing diabetic foot ulcers, with a higher complete healing rate compared to traditional wet dressings. Additionally, a study on a porcine collagen-derived matrix showed a significant reduction in wound size, suggesting that such matrices can effectively promote healing in diabetic foot ulcers. ^{1 2 3 4 5}

Is ProgenaMatrix safe for treating diabetic foot ulcers?

The Integra Flowable Wound Matrix, a similar advanced wound matrix, was found to be safe with no adverse effects reported in a study for diabetic foot ulcers. This suggests that similar products like ProgenaMatrix may also be safe for use. ^{5 6 7 8 9}

How does the treatment ProgenaMatrix™ differ from other treatments for diabetic foot ulcers?

ProgenaMatrix™ is unique because it combines a protease-modulating matrix with autologous growth factors (substances that help cells grow), enhancing the healing process of diabetic foot ulcers more effectively than using either component alone. ^{1 2 10 11 12}

What is the purpose of this trial?

This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

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

Synergistic action of protease-modulating matrix and autologous growth factors in healing of diabetic foot ulcers. A prospective randomized trial. [2007]

2. United States 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. [2016]

3. England pubmed.ncbi.nlm.nih.gov

New and experimental approaches to treatment of diabetic foot ulcers: a comprehensive review of emerging treatment strategies. [2007]

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

Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers. [2022]

5. Italy 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. [2022]

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

A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. [2022]

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

Cellular versus acellular grafts for diabetic foot ulcers: altering the protocol to improve recruitment to a comparative efficacy trial. [2018]

8. 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]

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

Advanced Biomaterials and Topical Medications for Treating Diabetic Foot Ulcers: A Systematic Review and Network Meta-Analysis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: an interim analysis. [2018]

11. England 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. [2022]

12. United States 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. [2022]