Novel Treatment of Diabetic Foot Ulcer by Autologous Stromal Vascular Fraction of Adipose Tissue

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional De Marseille

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

13 Sep 2024 → ongoing

Decision date (initial)

2024-09-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516342-19-00

EudraCT number

2021-002043-30

ClinicalTrials.gov

NCT02866565

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Conditions and MedDRA coding

Diabetic Foot ulcERs

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. Informed Consent Form Information and Signature
2. Female or male patient 18 years of age or older
3. 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)
4. Affiliation to social security.
5. Patient willing to wear the discharge system daily and the prescribed dressing throughout the study.
6. Patient with BMI 18.5 Kg/m² (in order to have sufficient fat tissue)
7. Good overall condition, based on history and clinical examination
8. 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.
9. 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).
10. UPD grade I-C or II-C as defined by the University of Texas Diabetic Wound Classification. University of Texas Appendix 1
11. Neuropathy confirmed by loss of protective sensation on monofilament test (Semmes-Weinstein 5.07 monofilament).
12. UPD located on a toe or on the foot
13. UPD with a surface area of between 1 and 15 cm2 after debridement
14. UPD refractory to conventional treatment for at least 2 months, including an appropriate wound care protocol.
15. No clinical signs of local wound infection (whether target UPD or not) localized to the lower limbs (as defined by IDSA/IWGDF infection criteria).

Exclusion criteria 29

1. Pregnant or breastfeeding women or women of childbearing age without effective contraception
2. Known hypersensitivity to human albumin.
3. Surgical revascularization or surgery of the lower limbs within the last month
4. Ischemic event (stroke, myocardial infarction) within 3 months of inclusion
5. Patient with renal failure requiring dialysis
6. Systemic infection not controlled by appropriate antibiotic treatment
7. Patient with documented osteomyelitis
8. Patient with active neoplasia, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressive therapy.
9. Patient treated for a chronic pathology requiring high-dose corticosteroid therapy (≥ 40 mg/d prednisolone or equivalent).
10. Patient with serious pathology that could lead to premature discontinuation of the study.
11. Patients with a history of coagulation disorders contraindicating surgical intervention
12. 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.
13. Congenital or acquired immune deficiency.
14. UPD with ischemia grade 3 according to WIfI classification (Mills JL Sr, 2014)
15. UPD with surgery or revascularization planned at any time during the time of the study
16. deep UPD defined as stage III by the University of Texas Diabetic Wound Classification (Appendix 1)
17. UPD clinically infected, as defined by IDSA/IWGDF infection criteria
18. UPD whose surface is covered by more than 20% black necrosis after debridement
19. UPD located on the scar of the amputation stump
20. UPD with carcinomatous degeneration
21. 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].
22. Adults protected by law (under guardianship or curatorship)
23. Minors
24. People staying in a health or social care establishment
25. People in emergency situations
26. Persons not covered by a social security scheme
27. 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
28. Patient participating in another clinical trial
29. Absence or refusal of informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. percentage (%) of wounds completely healed by week 20 (S20) post-injection

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional De Marseille

Sponsor organisation

Centre Hospitalier Regional De Marseille

Address

80 Rue Brochier

City

Marseille

Postcode

13005

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional De Marseille

Contact name

Patrice DARMON

Public contact point

Organisation

Centre Hospitalier Regional De Marseille

Contact name

Patrice DARMON

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 4 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications