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

NCT04405765 | Completed Phase 4 Results FDA Device

• 1 other identifier: 2020-0293
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Wound

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  Number of patients who achieve wound closure (complete epithelialization with no drainage)

  12 weeks

Secondary Outcomes (3)

• Duration of Negative Pressure Wound Therapy

  12 weeks

• Split Thickness Skin Grafting

  12 weeks

• Infection

  12 weeks

Study Arms (2)

Lyopreserved Stravix

ACTIVE COMPARATOR

Treated with NPWT and lyopreserved Stravix

Device: NPWT and lyopreserved Stravix

Cryopreserved Stravix

ACTIVE COMPARATOR

Treated with NPWT and cryopreserved Stravix

Device: NPWT and cryopreserved Stravix

Interventions

NPWT and lyopreserved Stravix DEVICE

Subjects will be treated with NPWT and lyopreserved Stravix

Lyopreserved Stravix

NPWT and cryopreserved Stravix DEVICE

Subjects will be treated with NPWT and lyopreserved Stravix

Cryopreserved Stravix

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Osiris Therapeutics: collaborator

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Tara Kristof - research coordinator
• Organization: University of Texas Southwestern Medical Center

tara.kristof@utsouthwestern.edu

214-648-9007

Study Officials

• Lawrence Lavery, DPM MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Research

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: June 22, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: July 24, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-07

Locations

US (1)