Cellular, Acellular, and Matrix-like Products for Diabetic Foot and Venous Leg Ulcers

Overseen By Madison Dunn

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Tiger Biosciences, LLC.

Must not be taking: Immunosuppressants, Chemotherapy, Biologics, others

Disqualifiers: Infection, 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

340 Participants Needed

Trial Summary

What is the purpose of this trial?

Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.

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 immunosuppressants, certain chemotherapy drugs, or high doses of corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment ACApatch™ and caregraFT™ for diabetic foot and venous leg ulcers?

Research on similar treatments, like human acellular dermal matrices, shows they can significantly speed up healing in diabetic foot ulcers, reducing healing time and improving the chance of healing compared to standard care. Additionally, a novel skin construct treatment showed promising results with complete wound closure in most patients within 8 weeks. ^{1 2 3 4 5}

Is the treatment with cellular, acellular, and matrix-like products for diabetic foot and venous leg ulcers safe?

The treatments, including the novel autologous homologous skin construct and human acellular dermal matrices, have shown no adverse events related to the treatment sites in studies, suggesting they are generally safe for use in humans. ^{1 2 3 4 6}

How does the treatment ACApatch™ and caregraFT™ differ from other treatments for diabetic foot and venous leg ulcers?

ACApatch™ and caregraFT™ are unique because they involve the use of cellular, acellular, and matrix-like products, which can help restore the natural healing environment in ulcers. These treatments may offer an advantage over standard care by potentially improving healing rates and outcomes for difficult-to-heal wounds, as seen with similar acellular matrix therapies. ^{1 2 3 7 8}

Eligibility Criteria

Adults over 21 with nonhealing diabetic foot ulcers (DFU) or venous leg ulcers (VLU) that have persisted for 4-52 weeks. DFUs must be on the foot and grade Wagner 1 or 2, VLUs should show less than a 40% size reduction in the last month. Participants need adequate blood flow to the limb and can't be pregnant, have severe diabetes complications, infections at ulcer sites, recent participation in other trials, or conditions affecting wound healing.

Inclusion Criteria

My ulcers are more than 2 cm apart after cleaning.

I am 21 years old or older.

My ulcer has been present for 1 month to 1 year.

Exclusion Criteria

My foot ulcer is not caused by diabetes.

(DFU) Subjects with glycated hemoglobin (HbA1c) greater than or equal to 12%

My wound is infected or was recently infected.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CAMPs plus SOC or SOC alone for the management of nonhealing diabetic foot and venous leg ulcers

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ACApatch™
• caregraFT™

Trial Overview The trial is testing ACApatch™ and caregraFT™ alongside standard treatments against standard treatment alone for chronic ulcers. It's a multicenter study where participants are randomly assigned to receive either one of these products plus usual care or just the usual care to see which approach helps heal ulcers better.

Participant Groups

Group I: VLU CAMP 2 + SOC = caregraFT™ + SOC Experimental Treatment 1 Intervention

caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue.

Group II: VLU CAMP 1 + SOC = ACApatch™ + SOC Experimental Treatment 1 Intervention

ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue.

Group III: DFU CAMP 2 + SOC = caregraFT™ + SOC Experimental Treatment 1 Intervention

caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue.

Group IV: DFU CAMP 1 + SOC = ACApatch™ + SOC Experimental Treatment 1 Intervention

ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue.

Group V: DFU Standard of Care Active Control 1 Intervention

Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.

Group VI: VLU Standard of Care Active Control 1 Intervention

Standard of care will be cleaning, debridement, and ulcer moisture balance.

Who Is Running the Clinical Trial?

Tiger Biosciences, LLC.

Lead Sponsor

Trials

8

Recruited

8,000+

SerenaGroup, Inc.

Collaborator

Trials

32

Recruited

3,900+

Findings from Research

A literature review of three clinical trials involving 154 patients showed that the human acellular dermal wound matrix (HADWM) significantly reduced the mean healing time of diabetic foot ulcers (DFUs) by 1.7 weeks compared to standard moist wound care.

Patients treated with HADWM had nearly four times the chance of healing their ulcers compared to those receiving standard care, indicating that HADWM could be a more effective option for difficult-to-heal wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human acellular dermal wound matrix for treatment of DFU: literature review and analysis. Reyzelman, AM., Bazarov, I.[2022]

The novel autologous homologous skin construct (AHSC) was tested in an open-label study with 11 patients suffering from diabetic foot ulcers (DFUs), showing that all ulcers successfully accepted the graft with no adverse events reported.

Ten out of the eleven DFUs closed completely within 8 weeks, with a median closure time of 25 days and an impressive 83% reduction in wound area at 4 weeks, indicating that AHSC could be an effective single-application treatment for DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. Armstrong, DG., Orgill, DP., Galiano, R., et al.[2022]

In a study involving 73 patients with diabetic foot ulcers, treatment with OASIS Wound Matrix resulted in a higher healing rate (49%) compared to Regranex Gel (28%) after 12 weeks, suggesting its potential effectiveness.

While the difference in healing rates was not statistically significant (P = .055), the results indicate that OASIS Wound Matrix is at least as effective as Regranex for treating full-thickness diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Niezgoda, JA., Van Gils, CC., Frykberg, RG., et al.[2022]

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 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]

CACIPLIQ, a novel heparan sulfate mimetic, was applied locally to 12 patients with type 2 diabetes suffering from chronic foot and lower extremity ulcers, leading to complete healing in all cases after an average of 4.92 months.

The treatment was well tolerated, indicating both safety and promising efficacy for managing difficult-to-heal ulcers in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a New Heparan Sulfate Mimetic Dressing in the Healing of Foot and Lower Extremity Ulcerations in Type 2 Diabetes: A Case Series. Papanas, N., Demetzos, C., Pippa, N., et al.[2017]

In a study of 12 patients with diabetic foot ulcers that did not heal with standard care, 83% achieved complete healing after 12 weeks of treatment with human reticular acellular dermal matrices (HR-ADMs).

The average time to complete wound closure was just 21 days, highlighting the efficacy of HR-ADMs in treating difficult-to-heal ulcers, with a cost of approximately $800 per patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Reticular Acellular Dermal Matrix in the Healing of Chronic Diabetic Foot Ulcerations that Failed Standard Conservative Treatment: A Retrospective Crossover Study. Zelen, CM., Orgill, DP., Serena, TE., et al.[2017]

A meta-analysis of 9 randomized clinical trials with 897 patients found that acellular matrix (AM) therapy significantly improved the complete healing rate of diabetic foot ulcers (DFUs) compared to standard therapy, with higher rates at both 12 weeks (73% vs. 42%) and 16 weeks (56% vs. 36%).

AM therapy not only led to faster healing times but also resulted in fewer adverse events, indicating a favorable safety profile for patients with full-thickness, noninfected, and nonischemic DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Acellular Matrix Therapy for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Clinical Trials. Huang, W., Chen, Y., Wang, N., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Human acellular dermal wound matrix for treatment of DFU: literature review and analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. [2022]

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

Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. [2022]

4. 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]

5. 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]

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

Efficacy of a New Heparan Sulfate Mimetic Dressing in the Healing of Foot and Lower Extremity Ulcerations in Type 2 Diabetes: A Case Series. [2017]

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

Human Reticular Acellular Dermal Matrix in the Healing of Chronic Diabetic Foot Ulcerations that Failed Standard Conservative Treatment: A Retrospective Crossover Study. [2017]

8. England pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Acellular Matrix Therapy for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Clinical Trials. [2022]