Controlled and randomized clinical trial of the use of plasma rich in growth factors (PRGF) in the treatment of foot ulcers in diabetic patients.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biotechnology Institue I Mas D S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

24 Oct 2024 → ongoing

Decision date (initial)

2024-05-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the efficacy of PRGF on the evolution of foot ulcer healing in diabetic patients with peripheral arterial disease at six months (assessment according to the RESVECH 2.0 index).

Conditions and MedDRA coding

Foot ulcers in diabetic patients with peripheral arterial disease

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - Patients aged at least 18 years - Diagnosis of type 1 or 2 diabetes - Presence of one or more ulcers below the malleoli - Ulcer size ranging from 1 to 25 cm2 - Absence of active infection as assessed using the fourth criterion of the SINBAD scale - Availability of observation during the study period - Properly completed patient informed consent

Exclusion criteria 1

1. - Positive markers for HCV, AfHBs, HIV-I/II or TP - Diabetes mellitus with poor metabolic control (evidence of glycosylated hemoglobin > 9%) - Active systemic infection - History of cancerous or precancerous lesions in the area of intervention - On active treatment with other local treatments at the site of treatment - On active treatment with immunosuppressants and/or other drugs contraindicating blood collection - History of allergy to blood derivatives - Previous diagnosis of coagulopathies - Regular and continuous treatment (≥ 3 months) with NSAIDs (with the exception of the use of acetylsalicylic acid) - Pregnancy or women of childbearing age not taking effective contraceptive measures. These methods are, according to the recommendations of the Clinical Trial Facilitation Group (CTFG) Contraception Working Group (CTFG) (V1.1), the following: Hormonal contraception associated with ovulation inhibition, intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal ligation, vasectomy partner, sexual abstinence - Breastfeeding women - Treatment with monoclonal antibodies - Any inabilities to participate in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months

Secondary endpoints 6

1. - Age - Sex - Toxic habits (tobacco, alcohol) - Body mass index
2. - Time of evolution - Etiology (Type of diabetes) - Ulcer dimensions (area and depth) - Previous treatments
3. - Change in ulcer size at three and six months (%) (area and depth) - Frequency of ulcers with complete closure at three and six months (%) - Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months
4. - Assessment of the severity of the ulcer as measured by the SINBAD scale at baseline, 3 and 6 months. -Assessment of pain and quality of life at baseline, three and six months using the EQ-5D-5L scale - Cost of wound closure
5. - Incidence and type of adverse events - Presence of infection according to SINBAD criterion 4 at baseline, three and six months - Frequency and type of deficiencies of the medical devices used for PRGF preparation
6. - Biomarkers involved in tissue damage repair

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biotechnology Institue I Mas D S.L.

Sponsor organisation

Biotechnology Institue I Mas D S.L.

Address

Calle San Antonio 15 5a

City

Vitoria-Gasteiz

Postcode

01015

Country

Spain

Scientific contact point

Organisation

Biotechnology Institue I Mas D S.L.

Contact name

Mohammad Alkhraisat Almasoud

Public contact point

Organisation

Biotechnology Institue I Mas D S.L.

Contact name

Mohammad Alkhraisat Almasoud

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 13 files

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

Application history

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