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Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

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ClinicalTrials.gov Identifier: NCT02987101
Recruitment Status : Unknown
Verified December 2016 by Navid Toyserkani, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Navid Toyserkani, Odense University Hospital

Brief Summary:
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 as an adjunct to standard wound care.

Condition or disease Intervention/treatment Phase
Leg Ulcer Procedure: Liposuction Other: Standard wound care Drug: Adipose-Derived Regenerative Cells Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
Study Start Date : November 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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.

Procedure: Liposuction
Adipose tissue is harvested by liposuction from either abdomen or thighs.

Other: Standard wound care
Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.

Drug: Adipose-Derived Regenerative Cells
Cells isolated from adipose-derived tissue will be injected locally around and under the wound.

Standard of care
Standard wound care is given independent of this study.
Other: Standard wound care
Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Distal blood pressure measurement [ Time Frame: 6 months ]
    Change in distal blood pressure measurement before and 6 months after treatment

  2. Transcutaneous oxygen tension [ Time Frame: 6 months ]
    Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.

  3. Treatment-related adverse events [ Time Frame: 6 months ]
    Monitoring of any side effects or complications related to intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987101


Contacts
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Contact: Navid M Toyserkani, MD +4550383833 navid.m.toyserkani@rsyd.dk

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Navid M Toyserkani, MD    +4550383833    navid.m.toyserkani@rsyd.dk   
Principal Investigator: Navid M Toyserkani, MD         
Sponsors and Collaborators
Odense University Hospital
Investigators
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Study Chair: Jens A Sørensen, MD PhD Dept. Plastic Surgery, OUH, Consultant, Professor

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Responsible Party: Navid Toyserkani, Resident, PhD fellow, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02987101     History of Changes
Other Study ID Numbers: S-201502002
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases