Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
NCT ID: NCT05519501
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
16 participants
INTERVENTIONAL
2021-10-10
2024-08-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers
NCT05095389
Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers
NCT05506215
Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation
NCT05072353
A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers
NCT02799121
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
NCT01181440
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SyntrFuge System
Adipose tissue microsized via the SyntrFuge System
SyntrFuge System
Microsized Adipose Tissue
Standard of Care
Offloading
Standard of Care
Offloading
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SyntrFuge System
Microsized Adipose Tissue
Standard of Care
Offloading
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Syntr Health Technologies, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Roanoke
Roanoke, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHT-SYN-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.