CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
GrafixPL PRIMEbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03742440
NCT03742440Phase 4Completed
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GrafixPL PRIME Evaluation Case Study

University of Texas Southwestern Medical Center·interventional·Posted Nov 15, 2018·Updated Jul 24, 2023

In Brief

A Phase 4 clinical trial evaluating GrafixPL PRIME for Diabetic Foot Ulcer. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesUnited States
CollaboratorsOsiris Therapeutics

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedNov 15, 2018
Enrollment StartNov 20, 2018
Primary CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.6 years ago

Interventions

GrafixPL PRIMEbiological

GrafixPL PRIME