Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04405765 |
| Other study ID # |
2020-0293 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 22, 2021 |
| Est. completion date |
July 7, 2022 |
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
This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare
lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.
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 3. Complete SF-36, EuroQol 5 dimensions (EQ-5D) and
PROMIS® Baseline (may be done as same day as screening procedures or within +2 days of
screening and before start of Therapy/Treatment Phase)
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. Document ulcer classification.
5. Perform debridement and obtain tissue collection (3 tissue and 1 bone).
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). These values are the
baseline measurements for calculating wound closure rate at the two-week run-in visit.
7. Perform hyperspectral imaging of dorsal and plantar aspects of the foot.
8. Perform neuropathy assessment
9. Collect all relevant concomitant medication (antibiotics, antifungals and other
anti-infective therapies)
10. Place Stravix (lyo or cryo per randomization schedule) and dress wound for NPWT therapy.
11. Document size of Stravix used.
12. Disburse subject stipend Therapy/Treatment Phase (Weekly visits +/- 4 days)
Study Visit 1-11:
1. Assess target ulcer (if wound has closed, document as such, skip to step 5).
2. Document time on/off NPWT if applicable.
3. Perform standardized photography of the study wound when NPWT is removed.
4. If Stravix is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth
(cm) using the inSight device - if the wound is deemed closed by the physician, skip to
EOS visit.
5. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is
active or closed.
6. Debride wound if indicated. Re-measure wound if surgical debridement is performed prior
to dressing the wound.
7. Collect all relevant concomitant medication.
8. If wound is still active, redress the wound with assigned Stravix (if removed for
debridement) and NPWT. Document all dressings applied including size of Stravix.
9. Disburse subject stipend
10. Note: at week 4, if wound is not ready for grafting, remove existing Stravix and replace
with new piece of Stravix (per randomization schedule)
11. Assess for AE/SAEs and/or follow up on previous AE/SAEs.
Study Visit Closed 1. When a subject's study wound has closed, they will perform the EOS
evaluation.
Study Visit 12/EOS:
1. At the time of wound closure, subjects will perform EOS visit.
2. A subject whose wound is not deemed closed (epithelialized with no drainage) by
physician at week 12 will exit from the study after the week 12 wound evaluation.
3. Assess index ulcer.
4. If wound has not closed, perform standardized photography of the study wound.
5. If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth
(cm) using the inSight device.
6. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is
active or healed.
7. If wound has not closed, redress the wound per physician-directed standard of care.
8. Administer Patient Reported Outcome (PRO) (questionnaires).
9. Collect all relevant concomitant medication
10. Perform EOS visit documentation
11. Follow up on AE/SAEs that have been reported 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.
