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Completed

NCT Number: NCT05519501

Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers

This is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the SyntrFuge™ system in diabetic patients with diabetic foot ulcers. In particular, it will be evaluated whether the microsized fat graft will be able to shorten the healing times of these wounds. Patients will be randomized to the treatment group with adipose tissue processed with the SyntrFuge™ system (injection of autologous microsized adipose tissue) or to the control group represented by the standard of care.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roanoke

Roanoke, Virginia, 24153, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who have Diabetic Foot Ulcer located at the plantar or dorsal aspect of the foot or the heel with a surface area of 1.0cm2 - 25cm2
  • Index ulcer has been present for greater than four weeks
  • Diabetics included will be those with HbA1c ≤ 12%
  • Subjects aged 18 - 85, inclusive
  • The target ulcer has been offloaded for at least 14 days

Exclusion criteria

  • Subjects without decisional capacity
  • Subjects unable to give informed, written consent
  • Subjects with active infection (redness, swelling, pain, suppuration)
  • Subjects with active osteomyelitis to the index ulcer
  • Subjects with previous treatment with Negative Pressure Wound Therapy, growth factors, radiation, hyperbaric O2, or bioengineered tissue product within 30 days of Screening
  • Subjects with a previous diagnosis of HIV or Hep C
  • Subject is pregnant or breast feeding
  • Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
  • Subjects under corticosteroid therapy, unless taking dose of 5mg/dl or less
  • Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Treatment and study plan

SyntrFuge System

Device

Microsized Adipose Tissue

Standard of care

Procedure

Offloading

Primary outcomes

  1. Percent of subjects with study wound deemed closed at 12 weeks

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Syntr Health Technologies, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2022
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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