Status:
COMPLETED
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
Lead Sponsor:
Acera Surgical, Inc.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used...
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: Allo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03312595
Start Date
September 14 2017
End Date
July 30 2018
Last Update
September 16 2025
Active Locations (5)
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1
Associated Foot & Ankle Specialists
Phoenix, Arizona, United States, 85015
2
Arizona Reginal Medical Research
Tucson, Arizona, United States, 85710
3
SAVAHCS
Tucson, Arizona, United States, 85723
4
Advanced Foot Care And Clinical Research Center
Fresno, California, United States, 93722