Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04405050 |
Other study ID # |
2020-0268 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
June 2021 |
Est. completion date |
July 2023 |
Study information
Verified date |
July 2023 |
Source |
University of Texas Southwestern Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare the efficacy of Restrata compared to Negative
Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds.
Description:
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.