- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02987101
Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction (SVF) as an adjunct to standard wound care.
The plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and these are randomized in two groups of which one receives standard wound care only and the other group receives autologous stromal vascular fraction treatment in addition to standard wound care.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Navid M Toyserkani, MD
- Phone Number: +4550383833
- Email: navid.m.toyserkani@rsyd.dk
Study Locations
-
-
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Odense, Denmark, 5000
- Recruiting
- Odense University Hospital
-
Contact:
- Navid M Toyserkani, MD
- Phone Number: +4550383833
- Email: navid.m.toyserkani@rsyd.dk
-
Principal Investigator:
- Navid M Toyserkani, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Arteriovenous chronic leg ulcer
- Present beyond 4 months
- Conservative treatment not leading to progress
- Wound size between 2-30cm2
- ankle-brachial index (ABI) ( 50-90% and/or toe pressure 50-70% and where ankle pressure > 60 mmHg or toe pressure > 40 mmHg
- Written informed consent
Exclusion Criteria:
- Uncontrolled wound infection
- Osteomyelitis
- Hemoglobin <6.0mmol/L
- HbA1c >80mmol/mol
- Underlying malignancy
- Pregnancy or lactating
- Renal insufficiency requiring dialysis
- Charcot foot
- Underlying malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Autologous SVF + Standard of care
local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study. |
Adipose tissue is harvested by liposuction from either abdomen or thighs.
Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
Cells isolated from adipose-derived tissue will be injected locally around and under the wound.
|
OTHER: Standard of care
Standard wound care is given independent of this study.
|
Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in wound size
Time Frame: 6 months
|
Photography is taken every 2 weeks until complete wound healing.
Final follow-up date regardless of complete wound healing or not is 6 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distal blood pressure measurement
Time Frame: 6 months
|
Change in distal blood pressure measurement before and 6 months after treatment
|
6 months
|
Transcutaneous oxygen tension
Time Frame: 6 months
|
Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.
|
6 months
|
Treatment-related adverse events
Time Frame: 6 months
|
Monitoring of any side effects or complications related to intervention
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jens A Sørensen, MD PhD, Dept. Plastic Surgery, OUH, Consultant, Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-201502002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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