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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519501
• Other study ID #: SHT-SYN-01
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2021
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Syntr Health Technologies, Inc.
• Contact: Ahmed Zobi, EMBA
• Phone: 949-992-5728
• Email: info[@]syntrhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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

2. Index ulcer has been present for greater than four weeks

3. Diabetics included will be those with HbA1c = 12%

4. Subjects aged 18 - 85, inclusive

5. The target ulcer has been offloaded for at least 14 days

Exclusion Criteria:

1. Subjects without decisional capacity

2. Subjects unable to give informed, written consent

3. Subjects with active infection (redness, swelling, pain, suppuration)

4. Subjects with active osteomyelitis to the index ulcer

5. Subjects with previous treatment with Negative Pressure Wound Therapy, growth factors, radiation, hyperbaric O2, or bioengineered tissue product within 30 days of Screening

6. Subjects with a previous diagnosis of HIV or Hep C

7. Subject is pregnant or breast feeding

8. Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions

9. Subjects under corticosteroid therapy, unless taking dose of 5mg/dl or less

10. Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• SyntrFuge System
Microsized Adipose Tissue

Procedure:
• Standard of Care
Offloading

Locations

Country	Name	City	State
United States	Roanoke	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Syntr Health Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects with study wound deemed closed at 12 weeks		12 weeks