Wound Healing DisorderNCT05509673
Lipofilling for Healing of Chronic Wounds
A study testing Lipofilling (sublesional fat grafting) in people with Wound Healing Disorder, run by University of Witten/Herdecke.
Trial summary
Chronic wounds remain a therapeutic and financial challenge for physicians and the health care systems. Innovative, cheap and effective treatment methods would be of immense value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing Disorder
- What is being tested?
- Lipofilling (sublesional fat grafting)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 29 Jun 2011to 6 Mar 2017
- 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
- Patients with leg ulcers of any origin (venous, arterial, mixed arterial-venous, diabetogenic, compressive)
- Age of ulcer > 6 weeks
- Ulcer size >= 1 cm (minimum diameter)
- Ulcer / wound with complete destruction of the epidermis (including basement membrane)
- Patient age > 18 years
- Patient Consent
Who cannot join
- Pregnancy
- Exposed tendons, ligaments, or bone if maximum diameter > 2 mm
- Ulcer size > 10 cm
- Immediately preceding vacuum bandage therapy (< 2 weeks)
- Possibilities for correcting the cause of the ulcer
About this study
Official title: Clinical Trial to Improve Wound Healing of Chronic Lower Leg Ulcers by Autologous Transplantation of Fat Tissue
Chronic wounds remain a therapeutic and financial challenge for physicians and the health care systems. Innovative, cheap and effective treatment methods would be of immense value. The sublesional fat grafting could be such treatment, although the effectiveness and safety have not been assessed in large randomized clinical trials. The aim of this trial was to analyse the effect of adipose tissue on the healing of chronic lower leg wounds. For this purpose, the wounds were surgically cleaned (wound debridement) and then fat was suctioned out from the stomach or thighs and then injected into the edges of the wound and under the wounds. The wounds are covered with a foam dressing that is changed every 3-4 days. There are controls on days 3, 7, 14 and 21 after the intervention and a follow-up examination 2 months after the intervention. The primary objective is the reduction of the wound area 14 days and 2 month after intervention. Secondary objectives are pain level of the wound, bacterial colonialisation of the wound and analysis of the grafted fat tissue (ammount of mesenchymal stem cells)
- Conditions
- Wound Healing Disorder
- Being tested
- Lipofilling (sublesional fat grafting)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipofilling (sublesional fat grafting)Other
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group received a fat grafting under the wound bed and into the wound edges. Receives: Other: Lipofilling (sublesional fat grafting) |
| Control group | No intervention | The control group received an injection of saline solution (0.9%) under the wound bed and into the wound edges. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of wound area
The reduction of the wound area from intervention to 14 days and 2 month post-intervention
Measured: 14 days and 2 month
Secondary outcomes (2)
Pain wound
Subjective pain level of the patient in the area of the wound, measured by the visual analogue scale pre and post intervention
Measured: 2 month
Bacterial contamination wound
Wound swabs were taken pre intervention and on days 7, 14 and 21 after intervention
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start29 Jun 2011
- Primary completion30 Nov 2016
- Study completion6 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing DisorderStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Cologne-Merheim Medical Center (CMMC)
- Responsible party
- Sponsor
- Investigators
- Oliver C Thamm, MD, PhD, Principal investigator, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509673
- Sponsor's protocol ID
- 2010-001
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Improve Wound Healing of Chronic Lower Leg Ulcers by Autologous Transplantation of Fat Tissue
- ClinicalTrials.gov ID
- NCT05509673
- Acronym / sponsor ID
- 2010-001
- Conditions
- Wound Healing Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Cologne-Merheim Medical Center (CMMC)
- Study start
- 29 Jun 2011 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 22 Aug 2022 (actual)
- 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 wounds remain a therapeutic and financial challenge for physicians and the health care systems. Innovative, cheap and effective treatment methods would be of immense value. The sublesional fat grafting could be such treatment, although the effectiveness and safety have not been assessed in large randomized clinical trials. The aim of this trial was to analyse the effect of adipose tissue on the healing of chronic lower leg wounds. For this purpose, the wounds were surgically cleaned (wound debridement) and then fat was suctioned out from the stomach or thighs and then injected into the edges of the wound and under the wounds. The wounds are covered with a foam dressing that is changed every 3-4 days. There are controls on days 3, 7, 14 and 21 after the intervention and a follow-up examination 2 months after the intervention. The primary objective is the reduction of the wound area 14 days and 2 month after intervention. Secondary objectives are pain level of the wound, bacterial colonialisation of the wound and analysis of the grafted fat tissue (ammount of mesenchymal stem cells)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Lipofilling (sublesional fat grafting)The intervention group received a fat grafting under the wound bed and into the wound edges. |
| Control group | No intervention | –The control group received an injection of saline solution (0.9%) under the wound bed and into the wound edges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with leg ulcers of any origin (venous, arterial, mixed arterial-venous, diabetogenic, compressive)
- Age of ulcer > 6 weeks
- Ulcer size >= 1 cm (minimum diameter)
- Ulcer / wound with complete destruction of the epidermis (including basement membrane)
- Patient age > 18 years
Key exclusion criteria (5 listed)
- Pregnancy
- Exposed tendons, ligaments, or bone if maximum diameter > 2 mm
- Ulcer size > 10 cm
- Immediately preceding vacuum bandage therapy (< 2 weeks)
- Possibilities for correcting the cause of the ulcer
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 |
|---|---|---|
| Lipofilling (sublesional fat grafting) | Other | Intervention group |
Primary outcome
Reduction of wound area
Time frame: 14 days and 2 month
The reduction of the wound area from intervention to 14 days and 2 month post-intervention
2 secondary outcomes
Pain wound
Time frame: 2 month
Bacterial contamination wound
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Oliver C Thamm, MD, PhD principal investigator
University of Witten/Herdecke
Questions about this trial
What is this clinical trial studying?
A study testing Lipofilling (sublesional fat grafting) in people with Wound Healing Disorder, run by University of Witten/Herdecke.
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 5 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: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of wound area (time frame: 14 days and 2 month). 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 22 Aug 2022.