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

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ClinicalTrials.gov Identifier: NCT04405765
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : July 13, 2021
Sponsor:
Collaborator:
Osiris Therapeutics
Information provided by (Responsible Party):
Larry Lavery, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetic Wound Device: NPWT and lyopreserved Stravix Device: NPWT and cryopreserved Stravix Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lyopreserved Stravix
Treated with NPWT and lyopreserved Stravix
Device: NPWT and lyopreserved Stravix
Subjects will be treated with NPWT and lyopreserved Stravix

Active Comparator: Cryopreserved Stravix
Treated with NPWT and cryopreserved Stravix
Device: NPWT and cryopreserved Stravix
Subjects will be treated with NPWT and lyopreserved Stravix




Primary Outcome Measures :
  1. Complete wound closure [ Time Frame: 12 weeks ]
    To compare the incidence of complete wound closure of lyopreserved vs cryopreserved Stravix treated groups at 12 weeks post initial application.


Secondary Outcome Measures :
  1. To evaluate the outcomes between lyopreserved and cryopreserved Stravix: granulation [ Time Frame: 12 weeks ]
    Time to 100% granulation of deep structures (bone, tendon, etc)

  2. To evaluate the outcomes between lyopreserved and cryopreserved Stravix: duration of NPWT [ Time Frame: 12 weeks ]
    Duration of NPWT

  3. To evaluate the outcomes between lyopreserved and cryopreserved Stravix: surgical grafting to cover the wound. [ Time Frame: 12 weeks ]
    Time to surgical grafting to cover the wound.

  4. To evaluate the outcomes between lyopreserved and cryopreserved Stravix: time to complete wound closure [ Time Frame: 12 weeks ]
    Time to complete wound closure (complete epithelization with no drainage)

  5. To evaluate the outcomes between lyopreserved and cryopreserved Stravix: infection [ Time Frame: 12 weeks ]
    Level of infection

  6. To evaluate the outcomes between lyopreserved and cryopreserved Stravix: quality of life SF-36 [ Time Frame: 12 weeks ]
    Quality of Life - SF36

  7. To evaluate the outcomes between lyopreserved and cryopreserved Stravix: quality of life EQD5 [ Time Frame: 12 weeks ]
    Quality of Life - EQD5

  8. To evaluate the outcomes between lyopreserved and cryopreserved Stravix: quality of life PROMIS [ Time Frame: 12 weeks ]
    Quality of Life - PROMIS



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405765


Contacts
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Contact: Margaret Wright, RN 214-648-4776 margaret.wright@utsouthwestern.edu
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Tara Kristof    214-648-9007    Tara.Kristof@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Osiris Therapeutics
Investigators
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Principal Investigator: Lawrence Lavery, DPM MPH UT Southwestern Medical Center
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Responsible Party: Larry Lavery, Professor and Director of Research, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04405765    
Other Study ID Numbers: 2020-0293
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Wounds and Injuries