Phase 4 N=40 Treatment

GrafixPL PRIME Evaluation Case Study

Diabetic Foot Ulcer

Bottom Line

View on ClinicalTrials.gov: NCT03742440 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Jul 2020

Primary outcome: Primary: Number of Participants With Complete Closure of the Index Ulcer — 19 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: GrafixPL PRIME (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete Closure of the Index Ulcer	19	—
SECONDARY Time to Closure	40.0	—
SECONDARY Total Adverse Events	6; 17	—

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.

Eligibility Criteria

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03742440). 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.