Phase 4
Completed N=42
Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds
Diabetic Wound
Source: ClinicalTrials.gov NCT04405765 ↗
Enrolled (actual)
42
Serious AEs
12.5%
Results posted
May 2023
Primary outcomePrimary: Complete Wound Closure — 4; 7 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Wound Closure |
4; 7 | — |
| SECONDARY Duration of Negative Pressure Wound Therapy |
8.88; 4.66 | — |
| SECONDARY Split Thickness Skin Grafting |
2; 3 | — |
| SECONDARY Infection |
1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of a diabetes mellitus
- Men/women ≥21 years old
- Post-operative foot or ankle wounds sized >4cm2 that have presented for 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
Data sourced from ClinicalTrials.gov (NCT04405765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.