Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

NCT05095389 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2022-09-28

No results posted yet for this study

Summary

A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

ADRCs

Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer

OTHER

standard care

standard care

OTHER

Placebo

placebo

Sponsors & Collaborators

  • Paracrine, INC.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-12-31
Completion
2025-07-31
FDA Device
Yes

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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 NCT05095389 on ClinicalTrials.gov