Diabetic Foot Ulcer (DFU)RETRO-PLASTNCT07375160
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
An observational study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU), run by Cellution Biologics at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- What is being tested?
- dHPT, AIC
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 30 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- 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.
- Wound surface area is greater than 1cm2 at initial assessment.
- Clinical documentation of wound treatment.
Who cannot join
- AmchoPlast dHPT product was not applied to wound.
- HbA1C >12%.
- Presence of active osteomyelitis.
- Concurrent treatment for malignant disease.
- Use of other advanced biologics during treatment period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
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.
Read the detailed description
Around 10.5 million Medicare beneficiaries were affected by chronic wounds in 2019. A chronic wound is generally defined as any wound that fails to heal within a reasonable timeframe. Chronic wounds can be categorized into the following four groups: arterial, pressure, diabetic, and venous. Despite the well-established standard of care for chronic wounds, which includes sharp debridement, offloading, and maintaining proper moisture balance, a notable gap remains between historical outcomes and desired results in chronic wound care.
One approach to treating chronic wounds involves the use of dehydrated human placental tissues, which are defined as 'A broad category of biomaterials, synthetic materials, or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action. The application of dHTPs in chronic wound treatment provides several benefits, including creating a protective environment for healing, covering deep structures, aiding surgical closure, enhancing functional outcomes, and improving appearance. The cellular category of dHTPs includes allografts, which are human donor tissue samples intended for use in another human patient. Utilizing human amniotic membrane as an allograft displays considerable promise for chronic wound treatment.
- Being tested
- dHPT, AIC
- Keywords
- Chronic Wound, Leg Wound, Amniotic, Allograft, Placenta
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dHPT, AICBiological
Sterile dehydrated Human Amnion - Intermediate Layer - Chorion Membrane Allograft
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Closure for Target Ulcer
To evaluate the time to wound closure for patients treated with dHPT.
Measured: Up to 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start12 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellution Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375160
- Sponsor's protocol ID
- CELLBIO-2026-001
- Acronym
- RETRO-PLAST
- Status last verified
- Aug 2026
- First submitted
- 13 Jan 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No