Diabetic Foot Ulcer
Conditions
Keywords
Synthetic Hybrid-Scale Fiber Matrix, Diabetic Foot Ulcer, Epithelialization
Brief summary
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects.
Interventions
DEVICERestrata®
Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
DEVICEWound Dressing
Alginate or Foam wound dressing is intended to manage wounds.
Sponsors
Acera Surgical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient will remain blinded to the randomization assignment from the time of randomization assignment to the end of the treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is at least 18 years old 2. Patient is willing and capable of complying with all protocol requirements 3. Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period 4. Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) 5. Ulcer must be located at least in part on the foot or ankle 6. Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product 7. Wound size must be \< 30cm2 on the day of randomization and initial application of the study product, after initial debridement 8. Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization: 1. Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR 2. Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7 3. Toe-Brachial Index (TBI) of study extremity with results of \> 50 mmHg
Exclusion criteria
1. Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint 2. Patient is pregnant, breast feeding or planning to become pregnant 3. Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS) 4. Patient has a life expectancy less than six months as assessed by the investigator 5. Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period 6. Patient has an additional wound within 3 cm of the study wound 7. Hgb A1c \> 12% within 3 months prior to randomization in patients with a known history of diabetes 8. Patient not in reasonable metabolic control in the judgment of the investigator 9. Patient with a known history of poor compliance with medical treatments 10. Patient currently undergoing cancer treatment 11. Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis 12. Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period. Chronic oral steroid use is not excluded if dose is \< 10 mg per day for prednisone. 13. Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator 14. Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence 15. Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound 16. Study ulcer spontaneously closes during the 2-week run in period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 100% Re-epithelialization | 12 weeks | Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wound Area | 12 weeks | The difference in wound area from baseline to 100% re-epithelialization or week 12 will be summarized for each treatment group in each arm. Wound sizes were documented by the investigator at baseline to end of the treatment period for each participant. |
| Time to Wound Closure | Up to 12 Weeks | The number of weeks from initial application of study treatment until complete re-epithelialization is first identified. |
| Number of Treatment Applications | 12 weeks | The number of study treatment applications including the initial application until 12 weeks or until complete re-epithelialization, whichever occurs first. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness / Economic Model | 12 weeks | Cost data from the patient's treatment will be analyzed based on diagnoses, procedure and supply codes to determine cost efficacy and outcomes with the treatment pathway and related technology utilized during the course of care. |
| Incidence of Adverse Events | 12 weeks | — |
| Quality of Life - SF-36 | 12 weeks | The survey will be completed at the day of initial application and at either 12 weeks or at complete re-epithelialization |
Countries
United States
Participant flow
Pre-assignment details
There is a 2 week run-in period to confirm eligibility prior to treatment on study
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Synthetic Hybrid-Scale Fiber Matrix Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. | 25 |
| Treatment With Standard of Care Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds. | 21 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Amputation - no longer eligible | 1 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | patient non-compliance | 3 | 1 |
Baseline characteristics
| Characteristic | Treatment With Synthetic Hybrid-Scale Fiber Matrix | Treatment With Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 11 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 19 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 17 Participants | 38 Participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 21 |
| other Total, other adverse events | 6 / 25 | 2 / 21 |
| serious Total, serious adverse events | 2 / 25 | 2 / 21 |
Outcome results
Primary
Number of Participants With 100% Re-epithelialization
Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging.
Time frame: 12 weeks
Population: Patients who completed 12 weeks of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Synthetic Hybrid-Scale Fiber Matrix | Number of Participants With 100% Re-epithelialization | 14 Participants |
| Treatment With Standard of Care | Number of Participants With 100% Re-epithelialization | 6 Participants |
Secondary
Change in Wound Area
The difference in wound area from baseline to 100% re-epithelialization or week 12 will be summarized for each treatment group in each arm. Wound sizes were documented by the investigator at baseline to end of the treatment period for each participant.
Time frame: 12 weeks
Population: Per protocol population including participants that completed the primary study endpoint/treatment period without withdrawal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Synthetic Hybrid-Scale Fiber Matrix | Change in Wound Area | 89.3 Percentage of ulcer size decrease | Standard Deviation 20.8 |
| Treatment With Standard of Care | Change in Wound Area | 62.9 Percentage of ulcer size decrease | Standard Deviation 56 |
Secondary
Number of Treatment Applications
The number of study treatment applications including the initial application until 12 weeks or until complete re-epithelialization, whichever occurs first.
Time frame: 12 weeks
Population: The per protocol population, which includes all patients that completed the primary endpoint/treatment period without withdrawal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Synthetic Hybrid-Scale Fiber Matrix | Number of Treatment Applications | 6.8 Average number of treatment applications | Standard Deviation 3.5 |
| Treatment With Standard of Care | Number of Treatment Applications | 7.7 Average number of treatment applications | Standard Deviation 3.5 |
Secondary
Time to Wound Closure
The number of weeks from initial application of study treatment until complete re-epithelialization is first identified.
Time frame: Up to 12 Weeks
Population: Per protocol population who completed the primary endpoint/treatment period without withdrawal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Synthetic Hybrid-Scale Fiber Matrix | Time to Wound Closure | 6.57 Number of weeks | Standard Deviation 3 |
| Treatment With Standard of Care | Time to Wound Closure | 7.0 Number of weeks | Standard Deviation 2.9 |
Other Pre-specified
Cost Effectiveness / Economic Model
Cost data from the patient's treatment will be analyzed based on diagnoses, procedure and supply codes to determine cost efficacy and outcomes with the treatment pathway and related technology utilized during the course of care.
Time frame: 12 weeks
Other Pre-specified
Incidence of Adverse Events
Time frame: 12 weeks
Other Pre-specified
Quality of Life - SF-36
The survey will be completed at the day of initial application and at either 12 weeks or at complete re-epithelialization
Time frame: 12 weeks