Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

NCT05687656 | Active Not Recruiting FDA Device

• 1 other identifier: TLS-IM-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs) Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound Healing area using digital image

  The primary endpoint for the study is assessment of ulcer area at Weeks 6 and 12 using the MolecuLight Imaging Device

  12 weeks

Secondary Outcomes (3)

• Wound Closure

  12 weeks

• Percentage area reduction

  12 weeks

• Adverse events

  12 weeks

Other Outcomes (2)

• Bacterial burden assessment

  12 weeks

• Presence of protease levels

  12 weeks

Study Arms (1)

InnovaMatrix AC porcine placental ECM therapy

EXPERIMENTAL

Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Device: InnovaMatrix AC porcine placental ECM therapy

Interventions

InnovaMatrix AC porcine placental ECM therapy DEVICE

All eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care moist wound therapy and offloading

InnovaMatrix AC porcine placental ECM therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who are willing and able to attend all follow up visits
• Subject has a known history of Type 1 or Type 2 diabetes with a HbA1c ≤12% . Has a diabetic foot ulcer classified by the Wagner classification 1 or 2 and at least 0.75cm2 and less than 5.0 cm2 in surface area as determined by photographic planimetry at the time of enrollment.
• Index ulcer characteristics:
• Ulcer present for ≥ 30 days prior to (Day 0)
• Index ulcer is located below the ankle: at least 50% of the ulcer surface area is below the malleolus.
• Subject has Body Mass Index (BMI) ≤ 45 at enrollment.
• Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days:
• Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, Or
• ABIs with results of ≥ 0.7 and ≤ 1.2, Or
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For ABPI \>1.2 TBI (Toe Brachial Index) \> 0.5.
• Patient able to ambulate at home or in the clinic with or without mobility aids
• \. The subject is willing to accept treatment with a porcine based product 9. The subject is medically stable, in the opinion of the investigator
• Index Ulcer Assessment:
• Penetrates down to muscle, tendon, or bone
• Presence of another diabetic foot ulcer within 2 cm of the index ulcer

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (5)

Three Rivers Hyperbaric and Wound Center

North Port, Florida, 34289, United States

Location

Serena Group Buffalo Research Center

Buffalo, New York, 14203, United States

Location

SerenaGroup Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

SerenaGroup Austin Research Center

Austin, Texas, 78701, United States

Location

Atrium Medical Center

Stafford, Texas, 77477, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Thomas E Serena, MD

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects will be treated with a weekly application for 12 weeks of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: January 18, 2023
• Study Start: October 6, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (5)