A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-12-31

Brief Summary

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The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

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Detailed Description

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Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.

Conditions

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Foot Ulcer, Diabetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental

MatriStem MicroMatrix and MatriStem Wound Matrix

Group Type EXPERIMENTAL

MatriStem

Intervention Type DEVICE

MatriStem MicroMatrix and MatriStem Wound Matrix

Comparator

Cellular Dermal Replacement Tissue

Group Type ACTIVE_COMPARATOR

Cellular Dermal Replacement Tissue

Intervention Type DEVICE

Cellular Dermal Replacement Tissue

Interventions

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MatriStem

MatriStem MicroMatrix and MatriStem Wound Matrix

Intervention Type DEVICE

Cellular Dermal Replacement Tissue

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject has a current diagnosis of type I or type II diabetes
* Subject's ulcer is on the forefoot or heel
* Subject has chronic ulcer - has been present for minimum of 4 weeks
* Subject's ulcer extends through the dermis and into the subcutaneous tissue
* Subject's HgbA1c \<12%
* Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest

Exclusion Criteria

* Subject has a known sensitivity to bovine- or porcine-derived products.
* Subject's ulcer is due to a non-diabetic etiology
* Subject's ulcer is over a Charcot deformity of the mid-foot
* Subject's random blood sugar readings are \>450 mg/dL
* Subject is on dialysis
* Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No