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

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah

Criteria

Inclusion Criteria:

1. Patients 18-85 years old.

2. Patients with chronic lower extremity wounds that are greater than 3 months, but less than 12 months old.

3. Patients with full thickness wounds.

4. Patients with at least one wound that is ≥5 cm2 and<75 cm2 in size.

5. Patients who have failed previous traditional therapies (such as: standard of care, hyperbaric oxygen therapy, debridement, moist dressings, off-loading and edema control).

Exclusion Criteria:

1. Patients admitted to the hospital at the time of enrollment.

2. Patients who are pregnant, nursing or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.

3. Suspicion of or diagnosis of osteomyelitis underlying the wound.

4. Patients who have received an investigational agent or intervention within the prior 30 days or plan to use within the study period.

5. Patients with thermal-related injuries, such as burns or frostbite or wounds over joints.

6. Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.

7. Patients who require skin grafting.

8. Patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia.

9. Patients with a history of prior drug abuse.