Diabetes Mellitus Foot UlcerNCT03085550
Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer
A study testing Fat grafting and Fat grafting + platelet rich plasma in people with Diabetes Mellitus Foot Ulcer, run by University College, London at 1 site in United Kingdom.
Trial summary
Conventional management of diabetic ulcers is associated with slow healing, high costs and repeated trips to clinic. Stem cells contained in fat grafts can differentiate into pro-healing cells and release growth factors with evidence suggesting a benefit in wound healing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus Foot Ulcer
- What is being tested?
- Fat grafting and Fat grafting + platelet rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 28 Oct 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female;
- Age 18-90 at the time of consent;
- Diabetic foot ulcer (DFU) measuring more than 0.5cm x 0.5cm and less than 10cm x 10cm;
- Wound with clean, healthy granulating bed, with minimal adherent slough;
- Patient understands and is willing to participate and can comply with weekly visits and follow-up regime.
Who cannot join
- Wound with active infection;
- Patients with underlying vascular insufficiency (ABPI<0.3);
- Uncontrolled Diabetes Mellitus, as measured by an HbA1c > 90mmol/mol;
- Presence of one or more medical conditions, including renal, hepatic, haematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study;
- Patient not fit for surgery (ASA classification > 4).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial to Compare Platelet-Rich Plasma and Autologous Fat Graft for Diabetic Ulcer
Conventional management of diabetic ulcers is associated with slow healing, high costs and repeated trips to clinic. Stem cells contained in fat grafts can differentiate into pro-healing cells and release growth factors with evidence suggesting a benefit in wound healing. Platelet-rich-plasma (PRP), an autologous blood-product, demonstrates pro-healing properties through releasing pro-healing factors and regulating angiogenesis. When used combination there is evidence of additional wound healing benefits.
The aim is to investigate the feasibility of conducting a randomised controlled trial with fat grafting and fat/PRP co-grafting as interventions for diabetic ulcers. We aim to develop pilot data which can power a multi-centre study. The aim of the trial would be to determine the feasibility of the trial by assessing recruitment, randomisation and retention of participants. We would also evaluate the rate of wound healing in diabetic ulcers when treated with conventional dressings, fat grafting alone and fat+PRP combination. The secondary aims will be to understand the mechanism of the healing process, the health related quality of life and patient satisfaction and the cost implications.
Read more
The study is a single-blinded randomised controlled trial of approximately 30 patients with three parallel treatment arms. Each patient will be followed up for 12 weeks and the rate and degree of wound healing will be assessed. Wound biopsies will be taken at Day 0, week 1 and week 4 and will undergo subsequent histological analysis to evaluate the mechanism of healing. The study is expected to last two years from recruitment of the first patient and will be conducted at Royal Free Hospital and UCL Division of Surgery and Interventional Science.
The combination of fat+PRP may provide diabetic patients the option of a single treatment with improved healing, shorter followup and a reduced cost burden. Validation of the mechanism of healing through histological analysis will confirm clinical findings and help guide future research.
Read the detailed description
RCT to compare fat grafting and fat grafting with PRP in chronic diabetic wounds.
- Conditions
- Diabetes Mellitus Foot Ulcer
- Being tested
- Fat grafting, Fat grafting + platelet rich plasma
- Keywords
- diabetic foot ulcer, diabetes mellitus, fat grafting, platelet rich plasma, wound healing
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat graftingProcedure or surgery
Single treatment fat grafting infiltrated into diabetic ulcer wound
Fat grafting + platelet rich plasmaProcedure or surgery
Single treatment fat grafting mixed with autologous platelet rich plasma infiltrated into diabetic ulcer wound. Autologous PRP is obtained using the ANGEL(TM) Concentrated Platelet Rich Plasma (cPRP) Separation Device which is FDA-regulated and CE certified
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Conventional dressings management |
| Fat grafting only | Experimental | Patients will undergo conventional fat harvesting as per Coleman technique and infiltration of fat into diabetic ulcer wound bed in 1cc:10cm2 fat:wound size ratio Receives: Procedure: Fat grafting |
| Fat grafting + Platelet rich plasma | Experimental | Patients will undergo conventional fat harvesting as per Coleman technique. Fat will be mixed with autologous PRP and infiltrated into diabetic ulcer wound bed in 1cc:10cm2 fat:wound size ratio Receives: Procedure: Fat grafting + platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of wound healing
Comparison of rate of wound healing between each group
Measured: 12 weeks
Degree of wound healing
Comparison of degree of wound healing (50% and 100% re-epithelialisation)
Measured: 12 weeks
Secondary outcomes (4)
Mechanism of wound healing
Histological analysis of wound biopsies from each group at day 0, week 1 and week 4
Measured: 12 weeks
Health related quality of life
Patient quality of life with each procedure
Measured: 12 weeks
Cost implications
Cost implications of each treatment arm as per NHS coding practice
Measured: 12 weeks
Patient reported outcome measures
Patient reported outcome measures of satisfaction of each procedure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Feb 2018
- Primary completion2 Jul 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Foot UlcerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Smith, MBChB, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085550
- Sponsor's protocol ID
- 16/LO/2261
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nolan GS, Smith OJ, Heavey S, Jell G, Mosahebi A. Histological analysis of fat grafting with platelet-rich plasma for diabetic foot ulcers-A randomised controlled trial. Int Wound J. 2022 Feb;19(2):389-398. doi: 10.1111/iwj.13640. Epub 2021 Jun 24.
PubMed 34169656Smith OJ, Leigh R, Kanapathy M, Macneal P, Jell G, Hachach-Haram N, Mann H, Mosahebi A. Fat grafting and platelet-rich plasma for the treatment of diabetic foot ulcers: A feasibility-randomised controlled trial. Int Wound J. 2020 Dec;17(6):1578-1594. doi: 10.1111/iwj.13433. Epub 2020 Jul 7.
PubMed 32633854
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Compare Platelet-Rich Plasma and Autologous Fat Graft for Diabetic Ulcer
- ClinicalTrials.gov ID
- NCT03085550
- Acronym / sponsor ID
- 16/LO/2261
- Conditions
- Diabetes Mellitus Foot Ulcer
- Keywords
- diabetic foot ulcer, diabetes mellitus, fat grafting, platelet rich plasma, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 21 Mar 2017 (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.
Conventional management of diabetic ulcers is associated with slow healing, high costs and repeated trips to clinic. Stem cells contained in fat grafts can differentiate into pro-healing cells and release growth factors with evidence suggesting a benefit in wound healing. Platelet-rich-plasma (PRP), an autologous blood-product, demonstrates pro-healing properties through releasing pro-healing factors and regulating angiogenesis. When used combination there is evidence of additional wound healing benefits.
The aim is to investigate the feasibility of conducting a randomised controlled trial with fat grafting and fat/PRP co-grafting as interventions for diabetic ulcers. We aim to develop pilot data which can power a multi-centre study. The aim of the trial would be to determine the feasibility of the trial by assessing recruitment, randomisation and retention of participants. We would also evaluate the rate of wound healing in diabetic ulcers when treated with conventional dressings, fat grafting alone and fat+PRP combination. The secondary aims will be to understand the mechanism of the healing process, the health related quality of life and patient satisfaction and the cost implications.
The study is a single-blinded randomised controlled trial of approximately 30 patients with three parallel treatment arms. Each patient will be followed up for 12 weeks and the rate and degree of wound healing will be assessed. Wound biopsies will be taken at Day 0, week 1 and week 4 and will undergo subsequent histological analysis to evaluate the mechanism of healing. The study is expected to last two years from recruitment of the first patient and will be conducted at Royal Free Hospital and UCL Division of Surgery and Interventional Science.
The combination of fat+PRP may provide diabetic patients the option of a single treatment with improved healing, shorter followup and a reduced cost burden. Validation of the mechanism of healing through histological analysis will confirm clinical findings and help guide future research.
Detailed description
RCT to compare fat grafting and fat grafting with PRP in chronic diabetic wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Conventional dressings management |
| Fat grafting only | Experimental | Procedure: Fat graftingPatients will undergo conventional fat harvesting as per Coleman technique and infiltration of fat into diabetic ulcer wound bed in 1cc:10cm2 fat:wound size ratio |
| Fat grafting + Platelet rich plasma | Experimental | Procedure: Fat grafting + platelet rich plasmaPatients will undergo conventional fat harvesting as per Coleman technique. Fat will be mixed with autologous PRP and infiltrated into diabetic ulcer wound bed in 1cc:10cm2 fat:wound size ratio |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female;
- Age 18-90 at the time of consent;
- Diabetic foot ulcer (DFU) measuring more than 0.5cm x 0.5cm and less than 10cm x 10cm;
- Wound with clean, healthy granulating bed, with minimal adherent slough;
- Patient understands and is willing to participate and can comply with weekly visits and follow-up regime.
Key exclusion criteria (5 listed)
- Wound with active infection;
- Patients with underlying vascular insufficiency (ABPI<0.3);
- Uncontrolled Diabetes Mellitus, as measured by an HbA1c > 90mmol/mol;
- Presence of one or more medical conditions, including renal, hepatic, haematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study;
- Patient not fit for surgery (ASA classification > 4).
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 |
|---|---|---|
| Fat graftingSingle treatment fat grafting infiltrated into diabetic ulcer wound | Procedure or surgery | Fat grafting only |
| Fat grafting + platelet rich plasmaSingle treatment fat grafting mixed with autologous platelet rich plasma infiltrated into diabetic ulcer wound. Autologous PRP is obtained using the ANGEL(TM) Concentrated Platelet Rich Plasma (cPRP) Separation Device which is FDA-regulated and CE certified | Procedure or surgery | Fat grafting + Platelet rich plasma |
Primary outcome
Rate of wound healing
Time frame: 12 weeks
Comparison of rate of wound healing between each group
Degree of wound healing
Time frame: 12 weeks
Comparison of degree of wound healing (50% and 100% re-epithelialisation)
4 secondary outcomes
Mechanism of wound healing
Time frame: 12 weeks
Health related quality of life
Time frame: 12 weeks
Cost implications
Time frame: 12 weeks
Patient reported outcome measures
Time frame: 12 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 19 Oct 2020.
- Derived from this study: PubMed 34169656Nolan GS, Smith OJ, Heavey S, Jell G, Mosahebi A. Histological analysis of fat grafting with platelet-rich plasma for diabetic foot ulcers-A randomised controlled trial. Int Wound J. 2022 Feb;19(2):389-398. doi: 10.1111/iwj.13640. Epub 2021 Jun 24.
- Derived from this study: PubMed 32633854Smith OJ, Leigh R, Kanapathy M, Macneal P, Jell G, Hachach-Haram N, Mann H, Mosahebi A. Fat grafting and platelet-rich plasma for the treatment of diabetic foot ulcers: A feasibility-randomised controlled trial. Int Wound J. 2020 Dec;17(6):1578-1594. doi: 10.1111/iwj.13433. Epub 2020 Jul 7.
Related trials for Diabetes Mellitus Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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 Smith, MBChB principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat grafting and Fat grafting + platelet rich plasma in people with Diabetes Mellitus Foot Ulcer, run by University College, London at 1 site in United Kingdom.
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 5 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 19 Oct 2020. 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 United Kingdom. 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?
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?
Rate of wound healing (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085550, which also lists 2 linked publications.
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 19 Oct 2020.