Diabetic Foot Ulcer
Conditions
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 to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).
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
Interventions
DEVICERestrata TM Wound Matrix
The RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds
Sponsors
Acera Surgical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Wound Closed | Up to 14 weeks | from baseline at week 0 to 14 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wound Area From Baseline | Baseline and weekly for up to 14 weeks | Wound area measurements will be made via tracing acetate every week for 14 weeks. |
| Time to Wound Closure | Baseline up to 14 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restrata Wound Matrix Prospective, single armed, non-randomized study with direct assignment
Restrata Wound Matrix: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Restrata Wound Matrix | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 19 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 12 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Percentage of Participants With Wound Closed
from baseline at week 0 to 14 weeks
Time frame: Up to 14 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restrata Wound Matrix | Percentage of Participants With Wound Closed | 75 percentage of participants |
Secondary
Change in Wound Area From Baseline
Wound area measurements will be made via tracing acetate every week for 14 weeks.
Time frame: Baseline and weekly for up to 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restrata Wound Matrix | Change in Wound Area From Baseline | 96 % wound area change | Standard Deviation 10 |
Secondary
Time to Wound Closure
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.
Time frame: Baseline up to 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restrata Wound Matrix | Time to Wound Closure | 6.4 weeks | Standard Deviation 2.5 |