Leg UlcerNCT02987101
Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
A study testing Liposuction, Standard wound care and Adipose-Derived Regenerative Cells in people with Leg Ulcer, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer
- What is being tested?
- Liposuction, Standard wound care and Adipose-Derived Regenerative Cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled wound infection
- Osteomyelitis
- Hemoglobin <6.0mmol/L
- HbA1c >80mmol/mol
- Underlying malignancy
- Pregnancy or lactating
Show all 9Show fewer
- Renal insufficiency requiring dialysis
- Charcot foot
- Underlying malignancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Navid M Toyserkani, MD, +4550383833, navid.m.toyserkani@rsyd.dk
Navid M Toyserkani, MD
About this study
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.
Read the 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.
- Conditions
- Leg Ulcer
- Being tested
- Liposuction, Standard wound care, Adipose-Derived Regenerative Cells
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposuctionProcedure or surgery
Adipose tissue is harvested by liposuction from either abdomen or thighs.
Standard wound careOther
Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
Adipose-Derived Regenerative CellsDrug
Cells isolated from adipose-derived tissue will be injected locally around and under the wound.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Liposuction; Other: Standard wound care; Drug: Adipose-Derived Regenerative Cells |
| Standard of care | Other | Standard wound care is given independent of this study. Receives: Other: Standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Distal blood pressure measurement
Change in distal blood pressure measurement before and 6 months after treatment
Measured: 6 months
Transcutaneous oxygen tension
Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.
Measured: 6 months
Treatment-related adverse events
Monitoring of any side effects or complications related to intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navid Toyserkani, Odense University Hospital
- Investigators
- Jens A Sørensen, MD PhD, Study chair, Dept. Plastic Surgery, OUH, Consultant, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987101
- Sponsor's protocol ID
- S-201502002
- Status last verified
- Dec 2016
- First submitted
- 24 Nov 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
- ClinicalTrials.gov ID
- NCT02987101
- Acronym / sponsor ID
- S-201502002
- Conditions
- Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous SVF + Standard of care | Experimental | Procedure: Liposuction, Other: Standard wound care, Drug: Adipose-Derived Regenerative Cellslocal injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study. |
| Standard of care | Other | Other: Standard wound careStandard wound care is given independent of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Uncontrolled wound infection
- Osteomyelitis
- Hemoglobin <6.0mmol/L
- HbA1c >80mmol/mol
- Underlying malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiposuctionAdipose tissue is harvested by liposuction from either abdomen or thighs. | Procedure or surgery | Autologous SVF + Standard of care |
| Standard wound carePatients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses. | Other | Autologous SVF + Standard of care, Standard of care |
| Adipose-Derived Regenerative CellsCells isolated from adipose-derived tissue will be injected locally around and under the wound. | Drug | Autologous SVF + Standard of care |
Primary outcome
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.
3 secondary outcomes
Distal blood pressure measurement
Time frame: 6 months
Transcutaneous oxygen tension
Time frame: 6 months
Treatment-related adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens A Sørensen, MD PhD study chair
Dept. Plastic Surgery, OUH, Consultant, Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposuction, Standard wound care and Adipose-Derived Regenerative Cells in people with Leg Ulcer, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Navid M Toyserkani, MD (+4550383833, navid.m.toyserkani@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound size (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.