A Longitudinal Study to Evaluate an Extracellular Matrix (MatriStem®) for the Treatment of Diabetic Foot Ulcers (M-S-DFU-RCT)

A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Porcine Urinary Bladder-Derived Extracellular Matrix (MatriStem®) in the Management of Diabetic Foot Ulcers

This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem® plus standard local wound care versus standard local wound care alone in the treatment of diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks and ulcer recurrence with a 2 year follow-up.

Study Overview

• Status: Completed
• Conditions: Neuropathic Diabetic Foot Ulcer
• Intervention / Treatment: Device: MatriStem® [Urinary Bladder Matrix (UBM)]; Device: Mepilex® [Silicone foam dressing]

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Calvary Hospital Center for Curative and Palliative Wound Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects 18-85 years of age with diabetes mellitus (type 1 or type 2)
2. Subject's foot ulcer is on the plantar surface of the foot.
3. DFU has not healed after more than2 months of SOC treatment administered
4. Subject's ulcer must be Wagner type 1 or 2 (uninfected, extending through the dermis and into subcutaneous tissue or granulating but without exposure of tendon, bone, or joint capsule.
5. Subject's wound is free of necrotic debris (post debridement) and clinical infection, should be comprised of healthy, vascular tissue.
6. Subject's Ankle-Brachial Index (ABI) by Doppler method is ≥ 0.7
7. The subject has adequate circulation to the foot to allow for healing. This must be demonstrated by methods described in section 5.1
8. Subject's diabetes is under control as determined by the Investigator
9. Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period. The subject is willing and able to tolerate TCC. Subject is willing to comply with the monthly follow-up regimen for 32 weeks (8 months) The subject is able to return to the clinic if ulcer recurrence occurs
10. Subject or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment
11. No active malignancy except non-melanoma skin cancer

Exclusion Criteria:

1. Subject has clinical evidence of gangrene on any part of the affected foot
2. Subject has a Wagner type 3 or greater ulceration
3. The subject's ulcer is due to a non-diabetic etiology, Ulcers of arterial, venous stasis, pressure, radiation, traumatic, rheumatoid, vasculitis, collagen vascular disease, or other non-diabetic etiologies
4. Subject has a known sensitivity to bovine or porcine derived devices
5. Subject has one or more medical condition(s) including renal, hepatic, hematological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this wound healing study
6. Subject has or has had a malignant disease (other than cutaneous epithelioma) not in remission
7. Subject is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study
8. Subject has chronic osteomyelitis as determined by high resolution ultrasonography
9. Subject's ulcer is infected or accompanied by active cellulitis as determined by the Investigator
10. Subject has any condition(s) that seriously compromises the subject's ability to complete the study
11. Subject is pregnant or lactating at the time of treatment
12. Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, bacaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of enrollment. If Santyl or any other collagenase is used, a subject must have a washout period of 2 weeks before MatriStem® can be applied.
13. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization
14. Subject has a history of alcohol or drug abuse
15. Subject allergic to a broad spectrum of primary & secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
16. Subject is currently enrolled or participated within the previous 30 days of enrollment in another device, drug or biological trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urinary Bladder matrix (UBM); UBM covered with silicone foam dressing plus total contact cast	Device: MatriStem® [Urinary Bladder Matrix (UBM)]; Porcine derived urinary bladder extracellular matrix; Other Names: MatriStem
Active Comparator: Standard Care; Silicone foam dressing plus total contact cast	Device: Mepilex® [Silicone foam dressing]; primary wound dressing; Other Names: Mepilex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of wound healing	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of ulcer recurrence	1 year

Collaborators and Investigators

• Sponsor: Calvary Hospital, Bronx, NY
• Collaborators: Integra LifeSciences Corporation
• Investigators: Principal Investigator: oscar Alvarez, PhD, Calvary Hospital Director, Center for curative and palliative wound care

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: CA2014-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No