Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-16

Study Completion Date

2026-10-01

Brief Summary

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This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating chronic open wounds.

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Detailed Description

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This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus NeoThelium FT.

The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions. All subjects will complete two-week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks. Secondary endpoints consist of wound percentage area reduction rates and pain assessment.

Conditions

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Open Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The subject will be randomized to one of the following treatments:

* Standard of care
* NeoThelium FT in addition to standard of care

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Intervention: Standard of Care

Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading

Intervention: NeoThelium FT & Standard of Care

Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading

Group Type EXPERIMENTAL

NeoThelium FT

Intervention Type OTHER

NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.

Interventions

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Standard of Care

Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading

Intervention Type OTHER

NeoThelium FT

NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male or Female, 18 years of age or older
2. Subject has a medical diagnosis of "other" Open wound
3. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
4. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening
5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization
6. Subject has an Open wound without infection or clinically visible exposed bone
7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
8. Index ulcer has a maximum depth of 1cm at screening visit 1
9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization
10. Adequate circulation of wounds located below the knee demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.
11. Index ulcer is free of infection prior to randomization and during screening phase.
12. Index ulcer is free of necrotic debris prior to NeoThelium FT application
13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
14. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
15. Subject is able and willing to follow the protocol requirements
16. Subject had signed informed consent
17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

Exclusion Criteria

1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
2. Subject has a known life expectancy of \<1 year
3. Subject is unable to comply with protocol treatment
4. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.
5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
7. Known contraindications to tissue-engineered allograft
8. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
9. Subject is pregnant or breastfeeding
10. Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
12. Open wound with active infection
13. Wound depth with visible exposed bone
14. HBOT within 14 days prior to randomization
15. Revascularization surgery on the index wound leg within 30 days of screening phase
16. Index wound suspicious of neoplasm in the opinion of the principal investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No