RCT to Compare Restrata and NPWT to Heal Complex DFUs

Screening

1. Explain purpose and nature of the study and obtain signature on the informed consent document.
2. Screen the subject against protocol inclusion and exclusion criteria, including all pertinent tests, including pregnancy test if needed.

Baseline (may be done as same day as screening procedures)

1. Obtain general medical history and demographic information and social history
2. Complete a physical examination, body weight, height, and vital signs, including measurement of resting heart rate, respiratory rate, and blood pressure while seated.
3. Select target study ulcer
4. Obtain complete history pertinent to DFU disease including duration of the target ulcer, previous and current treatment.
5. Perform debridement and obtain tissue collection (3 tissue and 1 bone if applicable).
6. Perform standardized photography and measurement of the study wound (eKare or available camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device (eKare, Fairfax, VA).
7. Perform hyperspectral imaging of dorsal and plantar aspects of the foot.
8. Perform neuropathy assessment (monofilament, VPT)
9. Skin perfusion pressure (Sensilase)
10. Collect all relevant concomitant medication (antibiotics, steroids, and diabetes medications)
11. Complete questionnaires
12. Place Restrata and dress wound or apply NPWT therapy.
13. Submit subject stipend

Therapy/Treatment Phase

Study Visit 1-11:

1. Assess target ulcer (if wound has closed, document as such, skip to END OF STUDY VISIT (EOS).
2. Document time on/off NPWT if applicable.
3. If Restrata is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device - if the wound is deemed healed by the physician, skip to EOS visit.
4. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.
5. Debride wound if indicated. Re-measure wound if surgical debridement is performed prior to dressing the wound
6. Collect all relevant concomitant medication.
7. If wound is not healed, redress the wound with Restrata dressing (if removed for debridement) or NPWT.
8. Disburse subject stipend
9. Note: at week 3, if wound is not ready for surgical closure, remove Restrata and replace with new piece of Restrata (per randomization schedule)
10. Assess for AE/SAEs and/or follow up on previous AE/SAEs.

Study Visit Closed

1. When a study wound has closed, we will perform the EOS evaluation.
2. If a wound has closed, the patient will enter the follow-up phase of the study.

Study Visit 12/EOS:

1. If the study wound closes prior to the 12-week study mark, subjects will perform EOS visit at the time of wound closure.
2. Assess target ulcer.
3. If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device.
4. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.
5. If wound has not closed, redress the wound per physician-directed standard of care.
6. Perform EOS visit documentation
7. Complete questionnaires
8. Follow up on AE/SAEs that have not yet been resolved.

Study Visit Follow-up

1. If the wound heals during the treatment phase or if the wound is not healed after 12 weeks, data from their electronic medical record will be evaluated to identify healing, time to heal, adverse events related to the wound.