Randomized Clinical Trial to Compare Restrata and Negative Pressure Wound Therapy (NPWT) to Heal Complex Diabetic Foot Wounds

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