Wounds and Injuries Clinical Trial
Official title:
A Phase I/II Clinical Trial To Determine Safety And Feasibility Of Using An Acellular Amniotic Fluid Application To Expedite Healing In Chronic Wounds
Verified date | August 2023 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
Status | Completed |
Enrollment | 1 |
Est. completion date | March 20, 2023 |
Est. primary completion date | March 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah Burn Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety - adverse events including serious adverse events | Safety and tolerability will be evaluated by the PI from the results of reported signs and symptoms and scheduled physical examinations. Unresolved AE's will be monitored for 1 year. | Up to 1 year after the last study visit. | |
Secondary | Feasibility - reduction in wound size | The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit. Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology. | Up to 8 months |
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