Diabetic Foot Ulcer, Venous Leg Ulcer
Conditions
Brief summary
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care. In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)
Interventions
DEVICESynthetic Hybrid-Scale Fiber Matrix
A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
DEVICEStandard of Care
To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
DEVICELiving Cellular Skin Substitute
An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
Sponsors
Acera Surgical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Participants with Diabetic Foot Ulcers: 1. Participant is at least 18 years old 2. Participant is willing and capable of complying with all protocol requirements 3. Participant or legally authorized representative (LAR) is willing to provide written informed consent 4. Participant has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) 5. Ulcer(s) must be located at least in part on the foot or ankle 6. Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy 7. Wound size must be \>1.0 cm\^2 and \< 25 cm\^2 on the day of randomization and initial application of the study product, after initial debridement 8. Participant has adequate circulation to the affected extremity(ies), 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(s) with results ≥40mmHg, OR 2. Ankle-Brachial Index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.3, OR 3. Toe-Brachial Index (TBI) of study extremity(ies) with results of ≥ 0.5
Exclusion criteria
for Participants with Diabetic Foot Ulcers: 1. Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint 2. Participant is pregnant, breast feeding or planning to become pregnant 3. Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS) 4. Participant has a life expectancy less than six months as assessed by the investigator 5. Participant has received skin substitutes during the screening period or within 14 days prior to beginning of screening period 6. Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart 7. Hgb A1c \> 12 percent within 3 months prior to randomization 8. Participant not in reasonable metabolic control in the judgment of the investigator 9. Participant with a known history of poor compliance with medical treatments 10. Participant currently undergoing cancer treatment 11. Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis 12. Participant is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the screening period or up to 30 days before the screening 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(s) 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. Participant unwilling or unable to safely utilize appropriate offloading device to unweight wound(s) 16. Study ulcer(s) experiences greater than 30 percent reduction over the 2-week screening period 17. Participant also has a venous leg ulcer that is enrolled into this study Inclusion Criteria for Participants with Venous Leg Ulcers: 1. Participant is at least 18 years old 2. Participant is willing and capable of complying with all protocol requirements 3. Participant or legally authorized representative (LAR) is willing to provide written informed consent 4. Participant has peripheral venous disease per investigator judgment or diagnostic confirmation 5. Ulcer(s) must be venous in origin, located on a lower extremity 6. Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy 7. Wound(s) size must be \>1.0 cm\^2 and \< 50 cm\^2 on the day of randomization and initial application of the study product, after initial debridement 8. Participant has adequate circulation to the affected extremity(ies), 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(s) with results ≥ 40mmHg, OR 2. Ankle-brachial index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.52, OR 3. Toe-Brachial Index (TBI) of study leg(s) with results of ≥ 0.5, OR 4. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected leg(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound | 12 weeks | The number of wounds in each treatment arm that achieved 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization |
| For Venous Leg Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound | 16 weeks | The number of wounds in each treatment arm with 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Wound Area | Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first. | Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements. Mean percent wound change will be calculated for each treatment arm/group with Week 1 as the baseline value. Change is calculated using the 2-week follow up visit after wound closure for wounds that achieved closure, or for wounds that did not achieve closure, the Week 12 wound area for DFUs and Week 16 wound area for VLUs. |
| Time to 100 Percent Epithelialization | 12 weeks for DFU wounds (16 weeks for VLU wounds), or until 100 percent epithelialization, whichever occurs first. | The number of weeks from initial application of study product until 100 percent epithelialization is first identified. |
| Total Number of Product Applications | Initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first | The number of study applications including the initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 6 Participants |
| Wound area at baseline in cm^2 | 5.0 cm^2 STANDARD_DEVIATION 4.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 10 | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 3 / 8 | 4 / 10 | 8 / 14 | 3 / 16 |
| serious Total, serious adverse events | 0 / 8 | 3 / 10 | 1 / 14 | 0 / 16 |
Outcome results
None listed