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Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds

NCT04438174 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-06-07

Study results available
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Summary

A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.

Conditions

  • Wounds and Injuries

Interventions

DRUG

Processed Amniotic Fluid

Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area

OTHER

Standard of Care Wound Treatment Regimen

ointment-based dressing and non-ointment-based dressings

Sponsors & Collaborators

Principal Investigators

  • Giavonni Lewis, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438174 on ClinicalTrials.gov