Status:
COMPLETED
Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Osiris Therapeutics
Conditions:
Diabetic Wound
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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.
Detailed 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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04405765
Start Date
June 22 2021
End Date
July 7 2022
Last Update
July 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390