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Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers

NCT06938685 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-06

No results posted yet for this study

Summary

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 diabetic foot ulcers.

Conditions

  • Diabetic Foot Ulcer

Interventions

OTHER

Standard of Care

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

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.

Sponsors & Collaborators

  • SygNola, LLC

    collaborator INDUSTRY

  • NuScience Medical Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Desmond Bell, DPM · SygNola, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2026-09-01
Completion
2026-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938685 on ClinicalTrials.gov