NCT04438174

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

A Phase I/II Clinical Trial To Determine Safety And Feasibility Of Using An Acellular Amniotic Fluid Application To Expedite Healing In Chronic Wounds

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The goal of our study is to assess, in an outpatient setting, the safety and the time to wound closure in chronic wounds treated with processed amniotic fluid (pAF). We will include patients with lower extremity full thickness wounds that are greater than 3 months old and less than 12 months old. The wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that requires skin grafting, or wounds with sinus tracts. Our primary objective is to determine the safety and feasibility of using pAF to treat patients with chronic wounds. The secondary objective is to determine the efficacy of pAF compared to standard of care in reducing wound area.

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2020-06-18
• Last updated: 2024-06-07
• Results posted: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study