Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

NCT05095389 | Unknown Phase 3 DMC FDA Device

• 1 other identifier: 2021-01
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Diabetic Foot Ulcer; DFU; Non-healing Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• DFU Closure Rate

  The rate of closure at 12 Weeks

  12 Weeks

Secondary Outcomes (1)

• Percent Reduction of Wound Area

  12 Weeks

Study Arms (2)

Standard Care plus ARDCs

EXPERIMENTAL

* All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. * All patients will receive standard care for their Diabetic Foot Ulcer. * Additionally, patients randomized to the ADRC arm will receive ADRCs

Device: ADRCs; Other: standard care

Standard Care plus Placebo

ACTIVE COMPARATOR

* All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. * All patients will receive standard care for their Diabetic Foot Ulcer. * Additionally, patients randomized to the Control arm will receive Placebo

Other: standard care; Other: Placebo

Interventions

ADRCs DEVICE

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

Standard Care plus ARDCs

standard care OTHER

standard care

Standard Care plus ARDCs; Standard Care plus Placebo

Placebo OTHER

placebo

Standard Care plus Placebo

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T1D or T2D
• Diabetic Foot Ulcer, from 1 to 12 months in duration
• Wagner Grade 1 or Superficial 2
• Adequate perfusion
• Able to undergo liposuction

You may not qualify if:

• Diabetic Foot Ulcer penetrates to capsule, tendon, or bone
• Active infection
• Non-diabetic neuropathy
• Significant cardiovascular event within 6 months before screening

Sponsors & Collaborators

• Paracrine, INC.: lead

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo is visually indistinguishable from Active Treatment. Every patient receives Standard Care, plus either Active Treatment or Placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel-Group, Double-Blind, Placebo Controlled

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: February 28, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: September 28, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share