What is NeoThelium FT studying for chronic pressure ulcers?

NeoThelium FT is being studied to see how well it helps heal chronic pressure ulcers and to check its safety. Researchers want to learn if adding this amnion skin graft to standard care can improve wound healing. NuScience Medical Biologics, LLC is leading this research to gather important information for patients and insurance decisions.

Who may be eligible for this pressure injury clinical trial?

Adults aged 18 years or older with a diagnosed Stage 2 or 3 pressure ulcer on the pelvis or lower extremity may be eligible. Participants must have ulcers sized between 1 and 30 cm² without infection and be able to follow treatment and offloading requirements. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this pressure injury clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07158658

Study of NeoThelium FT Skin Graft for Healing Chronic Pressure Ulcers in Adults

Led by NuScience Medical Biologics, LLC · Updated on 2026-05-06

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate how well NeoThelium FT Amnion Skin Graft works and how safe it is for treating chronic pressure ulcers. The study will take place at multiple medical centers using an open-label design, meaning both patients and researchers will know which treatment is being given. It is a post-marketing study intended to gather information on the treatments effectiveness and to support insurance reimbursement decisions. Participants will receive standard care plus weekly applications of NeoThelium FT, which is a dehydrated wound covering made from donated human placental tissue with amnion and chorion layers. Treatment includes wound cleansing, sharp debridement, applying NeoThelium FT, dressing for moisture balance, and offloading to reduce pressure. Patients will continue follow-ups according to the original schedule. During the study, participants will be assessed for wound healing progress including complete wound closure within 1 to 16 weeks, percent area reduction, wound closure at 2 weeks, and the number of grafts used. Researchers will monitor safety and treatment adherence throughout the study period, which is expected to last up to 16 weeks. This helps understand the treatments impact on chronic pressure ulcers over time.

CONDITIONS

Brief Title

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or Female, 18 years of age or older
Medical diagnosis of Pressure Injury/Ulcer located on the pelvis or lower extremity
Pressure Injury/Ulcer Stage 2 or 3 without infection
Index ulcer size between 1 cm² and 30 cm² at first treatment visit
Index ulcer depth of C 1 cm and compliant with continuous NPWT (75-100 mmHg) if applicable
Index ulcer depth over 1 cm and compliant with continuous NPWT (75-100 mmHg)
Use of offloading therapy while standing, sitting, and lying down for 7 days prior to first treatment
Adequate circulation of ulcer if on lower extremity, with ABI >0.7 and <1.3 or TBI >0.6 within 30 days prior
Index ulcer free of infection and necrotic debris prior to treatment
Female subjects of childbearing potential must have negative pregnancy test prior to treatment
Ability and willingness to follow protocol requirements
Signed informed consent
If multiple ulcers, they must be separated by at least 2 cm

You will not qualify if you...

Known life expectancy of less than 1 year
Inability to comply with protocol treatment
Major uncontrolled medical disorders affecting wound healing as judged by investigator
Active treatment for malignant disease or history of malignancy or radiation therapy at wound site
Comorbid conditions compromising safety as judged by investigator
Known contraindications to tissue-engineered allograft
Participation in other clinical trials with investigational drugs or products affecting wound healing
Pregnancy or breastfeeding
Recent or anticipated use of immunosuppressants, cytotoxic chemotherapy, or topical steroids to ulcer
Wound treated with CAMPs, tissue-engineered, or scaffold materials within 30 days prior
Pressure Injury/Ulcer Stage 4 or active osteomyelitis
Wound with visible exposed bone
Hyperbaric oxygen therapy within 14 days prior
Revascularization surgery on affected leg within 30 days prior
Ulcer suspicious of neoplasm as judged by investigator

Research Team

Angelina Ferguson, DNP

Sarah Moore, MBE

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Study of NeoThelium FT Skin Graft for Healing Chronic Pressure Ulcers in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria