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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03742440
Other study ID # 022018-035
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 20, 2018
Est. completion date March 1, 2020

Study information

Verified date July 2023
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data on other potential confounding factors that could affect healing such as medications, tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated. The objective of this study is to understand the use of this product to evaluate wound healing in 40 patients.


Description:

Screening and Enrollment: - Review and sign the Informed Consent and HIPAA Authorization - Review the inclusion and exclusion criteria If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days): Visit 0: - Demographics (such as age, gender, race or ethnicity) - Medical/Surgical and Social History, Current Antibiotics. - Laboratory Results - Vascular - ABI - Neurological evaluation - Monofilament and VPT - Vitals - Sitting blood pressure and Pulse rate, Height/Weight, and BMI - Wound debridement - eKare - Wound imaging measurement - Application of GrafixPL PRIME - Current Antibiotics - Offloading - Adverse Events - Source documentation Visits 1 - 11: - Wound debridement - eKare - Wound imaging measurement - Application of GrafixPL PRIME - Current Antibiotics - Offloading - Adverse Events - Source documentation Visit 12/End of Study (EOS) Visit: - Wound debridement - eKare - Wound imaging measurement - Current Antibiotics - Offloading - Adverse Events - Source documentation (End of Study will occur on the date the subject is healed)


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Able to provide informed consent - 18-90 years of age - Chronic foot ulceration below the ankle - persistent for 30 days or longer - Ankle Brachial Index (ABI) >0.5 (Bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery) Exclusion Criteria: - Unable to provide informed consent - <18 or >90 years of age - History of poor compliance with follow-up visits - Gangrene - Untreated Osteomyelitis - Widespread malignancy - Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines - Currently Pregnant or planning pregnancy during the course of intended participation in the study - Is nursing or actively lactating

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GrafixPL PRIME
GrafixPL PRIME

Locations

Country Name City State
United States UT Southwestern Medical Center at Dallas Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Osiris Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Complete Closure of the Index Ulcer Complete closure of the index ulcer, defined as 100% re-epithelialization as determined by the Investigator by week 12 or the End of Treatment Visit. 12 weeks
Secondary Time to Closure 12 weeks
Secondary Total Adverse Events There was no control arm in this study - everyone enrolled received treatment. Analysis of these data was separated into two groups - "closed wounds" and "not closed wounds." Wounds that closed achieved full epithelialization within the 12 week study time frame. Wounds that did not close did not achieve full epithelialization by the end of study visit. 12 weeks
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