Multi-Center, Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SyntrFuge System
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Microsized Fat Tissue, Adipose Tissue, DFU, Wound Management
Eligibility Criteria
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
Sites / Locations
- RoanokeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SyntrFuge System
Standard of Care
Arm Description
Adipose tissue microsized via the SyntrFuge System
Offloading
Outcomes
Primary Outcome Measures
Percent of subjects with study wound deemed closed at 12 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT05519501
First Posted
August 25, 2022
Last Updated
August 26, 2022
Sponsor
Syntr Health Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05519501
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syntr Health Technologies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Microsized Fat Tissue, Adipose Tissue, DFU, Wound Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SyntrFuge System
Arm Type
Experimental
Arm Description
Adipose tissue microsized via the SyntrFuge System
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Offloading
Intervention Type
Device
Intervention Name(s)
SyntrFuge System
Intervention Description
Microsized Adipose Tissue
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Offloading
Primary Outcome Measure Information:
Title
Percent of subjects with study wound deemed closed at 12 weeks
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Zobi, EMBA
Phone
949-992-5728
Email
info@syntrhealth.com
Facility Information:
Facility Name
Roanoke
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multi-Center, Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
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