- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312595
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Control Group: None (Utilize historical / published data on outcomes using standard of care)
Test Group: Treatment of DFUs with RestrataTM Wound Matrix
Study Type: Interventional
Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85015
- Associated Foot & Ankle Specialists
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Tucson, Arizona, United States, 85710
- Arizona Reginal Medical Research
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Tucson, Arizona, United States, 85723
- SAVAHCS
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California
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Fresno, California, United States, 93722
- Advanced Foot Care And Clinical Research Center
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Texas
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Dallas, Texas, United States, 75208
- Richard C. Galperin, DPM
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female age 18 or older
- Patient's ulcer must be diabetic in origin, located at least in part on the plantar surface and larger than 1cm2 after the run-in period. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two-week run in period will precede enrollment/randomization in the trial to document the indolent nature of the patients selected
- Patient does not exhibit clinical signs / symptoms of infection upon gross observation (at least 3 of the following: pain, redness, purulence, exudate, temperature) or have been diagnosed with an active infection at time of screening
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study
Patient has adequate control of diabetes, as demonstrated by one of the following within 30 days of screening:
- HbA1c < 12%
- Serum Creatinine < 3.0mg/dl
Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit:
Dorsum transcutaneous oxygen test (TcPO2) with results
≥30mmHg, OR
- ABIs with results of ≥0.7 and ≤1.5, OR
- Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
Exclusion Criteria:
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D)
- Patients whose index diabetic foot ulcers are greater than 25cm2
- Patient has an additional wound within 3cm of the study wound
- Patients not in reasonable metabolic control
- Patients with a known history of poor compliance with medical treatments
- Patients who have been previously enrolled into this study, or are presently participating in a clinical trial with DFU indications
- Patients with known or suspected local skin malignancy to the index diabetic ulcer
- Patients diagnosed with autoimmune connective tissues diseases
- Patients that have received a graft material on the study ulcer within the previous 30 days
- Patients who are pregnant or breast feeding
- Patients who are taking medications that are considered immune system modulator
- Study wound has closed > 30% over the two-week run-in period
- Patients with a known allergy to resorbable suture materials
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Restrata TM Wound Matrix
Prospective, single armed, non-randomized study with direct assignment
|
The RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Wound Closed
Time Frame: Up to 14 weeks
|
from baseline at week 0 to 14 weeks
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Up to 14 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Wound Area From Baseline
Time Frame: Baseline and weekly for up to 14 weeks
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Wound area measurements will be made via tracing acetate every week for 14 weeks.
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Baseline and weekly for up to 14 weeks
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Time to Wound Closure
Time Frame: Baseline up to 14 weeks
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The number of weeks until complete closure is first identified will be determined for each patient who has been deemed completely closed within the 14 week treatment period.
|
Baseline up to 14 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-RES-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Restrata TM Wound Matrix
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