Phase 4
Completed N=40
GrafixPL PRIME Evaluation Case Study
Source: ClinicalTrials.gov NCT03742440 ↗Enrolled (actual)
40
Serious AEs
12.5%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With Complete Closure of the Index Ulcer — 19 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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. Informational only — not medical advice.