Phase 4 N=42 Randomized Treatment

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

Diabetic Wound

Bottom Line

View on ClinicalTrials.gov: NCT04405765 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

May 2023

Primary outcome: Primary: Complete Wound Closure — 4; 7 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: NPWT and lyopreserved Stravix (Device); NPWT and cryopreserved Stravix (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jul 2022

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	—

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.

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

View full record on ClinicalTrials.gov →

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.