Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCellution Biologics
About this trial
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older.
Wound treated with Cellution Biologics AmchoPlast, a dehydrated human placental tissue (dHPT).
Wound present for greater than or equal to 30 days prior to treatment with dHPT.
Wound is not infected.
Disqualifiers
AmchoPlast dHPT product was not applied to wound.
HbA1C >12%.
Presence of active osteomyelitis.
Concurrent treatment for malignant disease.
Trial population
The study population will be drawn from wound clinic patient population that previously received treatment of their wound with a Cellution Biologics dHPT product
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
dHPT, AIC
Biological/VaccineSterile dehydrated Human Amnion - Intermediate Layer - Chorion Membrane Allograft
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Time to Closure for Target Ulcer
To evaluate the time to wound closure for patients treated with dHPT.
Time frame
Up to 8 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: