Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds

Study Overview
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Brief Summary
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This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.

Detailed Description
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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) Obtain general medical history and demographic information and social history Complete a physical examination, body weight, height, and vital signs, including measurement of resting heart rate, respiratory rate, and blood pressure while seated. Select target study ulcer Obtain complete history pertinent to DFU disease including duration of the target ulcer, previous and current treatment. Document ulcer classification. Perform debridement and obtain tissue collection (3 tissue and 1 bone). 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. Perform hyperspectral imaging of dorsal and plantar aspects of the foot. Perform neuropathy assessment Collect all relevant concomitant medication (antibiotics, antifungals and other anti-infective therapies) Place Stravix (lyo or cryo per randomization schedule) and dress wound for NPWT therapy. Document size of Stravix used. Disburse subject stipend Therapy/Treatment Phase (Weekly visits +/- 4 days) Study Visit 1-11: Assess target ulcer (if wound has closed, document as such, skip to step 5). Document time on/off NPWT if applicable. Perform standardized photography of the study wound when NPWT is removed. 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. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or closed. Debride wound if indicated. Re-measure wound if surgical debridement is performed prior to dressing the wound. Collect all relevant concomitant medication. 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. Disburse subject stipend Note: at week 4, if wound is not ready for grafting, remove existing Stravix and replace with new piece of Stravix (per randomization schedule) 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: At the time of wound closure, subjects will perform EOS visit. 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. Assess index ulcer. If wound has not closed, perform standardized photography of the study wound. If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed. If wound has not closed, redress the wound per physician-directed standard of care. Administer Patient Reported Outcome (PRO) (questionnaires). Collect all relevant concomitant medication Perform EOS visit documentation 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.

Official Title
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Prospective, Randomized, Single-Center Study to Compare Clinical Outcomes Between Cryopreserved and Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds

Conditions
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Diabetic Wound

Intervention / Treatment
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* Device: NPWT and lyopreserved Stravix
* Device: NPWT and cryopreserved Stravix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of a diabetes mellitus Men/women ≥21 years old Post-operative foot or ankle wounds sized >4cm2 that have presented for <1 year ABI ≥0.5 or toe pressures >30 mmHg Wounds indicated for treatment with NPWT Exclusion Criteria: Active Charcot arthropy Unable to use NPWT at home Untreated bone or soft tissue infection Is pregnant or plans to become pregnant Is nursing or actively lactating Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years. Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, 2-arm parallel assignment, randomized clinical trial. Stravix will be applied at initial visit with NPWT and will only be reapplied after 4 weeks if wound is not ready for grafting unless debridement is indicated.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lyopreserved Stravix<br>Treated with NPWT and lyopreserved Stravix | Device: NPWT and lyopreserved Stravix<br>* Subjects will be treated with NPWT and lyopreserved Stravix<br>|
| Active Comparator: Cryopreserved Stravix<br>Treated with NPWT and cryopreserved Stravix | Device: NPWT and cryopreserved Stravix<br>* Subjects will be treated with NPWT and lyopreserved Stravix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Wound Closure | Number of patients who achieve wound closure (complete epithelialization with no drainage) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Negative Pressure Wound Therapy | Number of days patient received negative pressure wound therapy after application of Stravix | 12 weeks | 
| Split Thickness Skin Grafting | Number of patients who received a split thickness skin graft | 12 weeks | 
| Infection | Number of patients who developed infection | 12 weeks |