Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

NCT02987101 | Unknown DMC

• 1 other identifier: S-201502002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Change in wound size

  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 Outcomes (3)

• Distal blood pressure measurement

  6 months

• Transcutaneous oxygen tension

  6 months

• Treatment-related adverse events

  6 months

Study Arms (2)

Autologous SVF + Standard of care

EXPERIMENTAL

local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.

Procedure: Liposuction; Other: Standard wound care; Drug: Adipose-Derived Regenerative Cells

Standard of care

OTHER

Standard wound care is given independent of this study.

Other: Standard wound care

Interventions

Liposuction PROCEDURE

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

Autologous SVF + Standard of care

Standard wound care OTHER

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

Autologous SVF + Standard of care; Standard of care

Adipose-Derived Regenerative Cells DRUG

Cells isolated from adipose-derived tissue will be injected locally around and under the wound.

Autologous SVF + Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled wound infection
• Osteomyelitis
• Hemoglobin \<6.0mmol/L
• HbA1c \>80mmol/mol
• Underlying malignancy
• Pregnancy or lactating
• Renal insufficiency requiring dialysis
• Charcot foot
• Underlying malignancy

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Leg Ulcer

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Jens A Sørensen, MD PhD

  Dept. Plastic Surgery, OUH, Consultant, Professor

  STUDY CHAIR

Central Study Contacts

Navid M Toyserkani, MD

CONTACT

+4550383833; navid.m.toyserkani@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, PhD fellow, MD

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

DK (1)