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NOVEL TREATMENT OF DIABETIC FOOT ULCER BY AUTOLOGOUS STROMAL VASCULAR FRACTION OF ADIPOSE TISSUE
EU CTIS ID: 2024-516342-19-00
What this study is testing
The main objective of this study is to evaluate the effectiveness of local SVF injection in the treatment of UPD refractory to conventional well conducted treatment (International Working group) in week 20.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed Consent Form Information and Signature
- UPD grade I-C or II-C as defined by the University of Texas Diabetic Wound Classification. University of Texas Appendix 1
- Neuropathy confirmed by loss of protective sensation on monofilament test (Semmes-Weinstein 5.07 monofilament).
- UPD located on a toe or on the foot
- UPD with a surface area of between 1 and 15 cm2 after debridement
- UPD refractory to conventional treatment for at least 2 months, including an appropriate wound care protocol.
You likely can't join if
- Pregnant or breastfeeding women or women of childbearing age without effective contraception
- Patient with serious pathology that could lead to premature discontinuation of the study.
- Patients with a history of coagulation disorders contraindicating surgical intervention
- Positive markers of the following active infectious diseases: Infection with immunodeficiency viruses HIV 1 and HIV 2; HTLV I infection; Hepatitis C virus infection Hepatitis B virus infection; Hepatitis C virus infection; Syphilis infection.
- Congenital or acquired immune deficiency.
- UPD with ischemia grade 3 according to WIfI classification (Mills JL Sr, 2014)
See the full eligibility criteria
Who can join
- Informed Consent Form Information and Signature
- UPD grade I-C or II-C as defined by the University of Texas Diabetic Wound Classification. University of Texas Appendix 1
- Neuropathy confirmed by loss of protective sensation on monofilament test (Semmes-Weinstein 5.07 monofilament).
- UPD located on a toe or on the foot
- UPD with a surface area of between 1 and 15 cm2 after debridement
- UPD refractory to conventional treatment for at least 2 months, including an appropriate wound care protocol.
- No clinical signs of local wound infection (whether target UPD or not) localized to the lower limbs (as defined by IDSA/IWGDF infection criteria).
- Female or male patient 18 years of age or older
- Type 1 or 2 diabetes mellitus patient with 10% HbA1C less than 1 month old (if this result is not available at the inclusion visit, analysis should be done during the 15-day assessment period)
- Affiliation to social security.
- Patient willing to wear the discharge system daily and the prescribed dressing throughout the study.
- Patient with BMI 18.5 Kg/m² (in order to have sufficient fat tissue)
- Good overall condition, based on history and clinical examination
- Women of childbearing age must have a negative pregnancy test (serum or urine) pregnancy test (detection threshold (sensitivity): 25 mIU hCG/ml). Patients of both sexes must use a reliable method of contraception in accordance with CTFG. In addition, contraception must be maintained throughout the treatment until the end of systemic exposure.
- UPD with "satisfactory" arterial blood supply to the lower limb bearing the target lesion: ischemia grade 0, 1 and 2 according to WIfI classification (Mills JL Sr, 2014).
What rules you out
- Pregnant or breastfeeding women or women of childbearing age without effective contraception
- Patient with serious pathology that could lead to premature discontinuation of the study.
- Patients with a history of coagulation disorders contraindicating surgical intervention
- Positive markers of the following active infectious diseases: Infection with immunodeficiency viruses HIV 1 and HIV 2; HTLV I infection; Hepatitis C virus infection Hepatitis B virus infection; Hepatitis C virus infection; Syphilis infection.
- Congenital or acquired immune deficiency.
- UPD with ischemia grade 3 according to WIfI classification (Mills JL Sr, 2014)
- UPD with surgery or revascularization planned at any time during the time of the study
- deep UPD defined as stage III by the University of Texas Diabetic Wound Classification (Appendix 1)
- UPD clinically infected, as defined by IDSA/IWGDF infection criteria
- UPD whose surface is covered by more than 20% black necrosis after debridement
- UPD located on the scar of the amputation stump
- Known hypersensitivity to human albumin.
- UPD with carcinomatous degeneration
- Reduction ≥ 30% of wound surface measured after the 15 days (Urgostart and adapted offloading system) compared with wound surface area measured at the inclusion visit (on the basis of wound surface measurement) [criterion assessed after the 15-day evaluation period, on the day of treatment].
- Adults protected by law (under guardianship or curatorship)
- Minors
- People staying in a health or social care establishment
- People in emergency situations
- Persons not covered by a social security scheme
- Adults deprived of their freedom by administrative or judicial decision, or subject to a legal protection measure, or who are unable to express their consent
- Patient participating in another clinical trial
- Absence or refusal of informed consent
- Surgical revascularization or surgery of the lower limbs within the last month
- Ischemic event (stroke, myocardial infarction) within 3 months of inclusion
- Patient with renal failure requiring dialysis
- Systemic infection not controlled by appropriate antibiotic treatment
- Patient with documented osteomyelitis
- Patient with active neoplasia, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressive therapy.
- Patient treated for a chronic pathology requiring high-dose corticosteroid therapy (≥ 40 mg/d prednisolone or equivalent).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.