Foot Ulcer, Diabetic
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMatriStem
MatriStem MicroMatrix and MatriStem Wound Matrix
DEVICECellular Dermal Replacement Tissue
Cellular Dermal Replacement Tissue
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Major 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 Major
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Wound Closure | 8 Weeks | Number of participants with incidence of complete wound closure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental MatriStem MicroMatrix and MatriStem Wound Matrix
MatriStem: MatriStem MicroMatrix and MatriStem Wound Matrix | 27 |
| Comparator Cellular Dermal Replacement Tissue
Cellular Dermal Replacement Tissue: Cellular Dermal Replacement Tissue | 29 |
| Total | 56 |
Baseline characteristics
| Characteristic | Experimental | Comparator | Total |
|---|---|---|---|
| Age, Continuous | 57 Years STANDARD_DEVIATION 9.8 | 58.5 Years STANDARD_DEVIATION 11.4 | 57.6 Years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 21 Participants | 22 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 27 | 2 / 29 |
| serious Total, serious adverse events | 5 / 27 | 2 / 29 |
Outcome results
Primary
Number of Participants With Complete Wound Closure
Number of participants with incidence of complete wound closure
Time frame: 8 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Number of Participants With Complete Wound Closure | 5 Participants |
| Comparator | Number of Participants With Complete Wound Closure | 2 Participants |