Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease

NCT06952998 | Recruiting Phase 4

• 1 other identifier: BTIIMD-01-EC-23-PIEDIABETICO
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized clinical trial that compares the effectiveness of Plasma Rich in Growth Factors (PRGF) with conventional treatment for healing foot ulcers in diabetic patients who also have peripheral arterial disease. The goal is to assess how well PRGF promotes healing over a six-month period.

Conditions

Foot Ulcers, Diabetic

Outcome Measures

Primary Outcomes (1)

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

  RESVECH 2.0 (Expected Results of the Assessment and Evolution of Chronic Wound Healing Index). Composed of 6 variables whose psychometric properties are detailed as follows: reliability through internal consistency with a Cronbach's α of 0.63 and a Cronbach's α based on typed items of 0.72 (indicating greater consistency the closer α is to 1); with a content validity index for the total of the scale higher than 0.9, being called RESVECH2.0. These 6 final items that it assesses are: 1. Injury dimensions 2. Depth/tissues affected 3. Edges 4. Type of tissue in the wound bed 5. Exudate 6. Infection-inflammation (signs-biofilm) Thus, each of them receives a score, considering a total value of 0 for the healed ulcer, and reaching a maximum of 35 points as the worst possible wound as a result of the evaluation.

  6 months follow up

Secondary Outcomes (9)

• Change in ulcer size at three and six months (percent) (area and depth)

  3 and 6 months follow up

• Frequency of ulcers with complete closure at three and six months (percent)

  3 and 6 months follow up

• Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months

  Baseline and three months follow up

• Assessment of amputation risk as measured by the WIfI scale at baseline, 3 and 6 months

  Baseline, 3 and 6 months follow up

• Assessment of pain and quality of life at baseline, three and six months using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)

  Baseline, 3 and 6 months follow up

Study Arms (2)

Topical application of Plasma Rich in Growth Factors (PRGF)

EXPERIMENTAL

The Principal Investigator, or duly delegated qualified personnel, is responsible for the preparation using the KMU10-TPC Kit (BTI Biotechnology Institute, S.L.).

Drug: Topical application of Plasma Rich in Growth Factors (PRGF)

Conventional treatment with adequate offloading and metabolic control, +/- antibiotic).

ACTIVE COMPARATOR

Manufacturer: N/A

Procedure: Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).

Interventions

Topical application of Plasma Rich in Growth Factors (PRGF) DRUG

Topical application of PRGF will be maintained each time the patient undergoes the conventional treatment. The frequency of conventional treatment will be determined by the health specialist according to the evolution of the ulcer. The treatment will be maintained until complete wound closure or until the end of the follow-up period (6 months).

Topical application of Plasma Rich in Growth Factors (PRGF)

Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic). PROCEDURE

Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic). The "TIME" dynamic wound closure strategy will be followed, which summarizes the four key points to stimulate the natural healing process: control of non-viable tissue, control of inflammation and infection, control of exudate and stimulation of the edges. After healing, chlorhexidine spray will be applied topically to these patients. The frequency of conventional treatment will be determined by the health specialist according to the evolution of the ulcer. Treatment will be maintained until complete wound closure or until the end of the follow-up period (6 months).

Conventional treatment with adequate offloading and metabolic control, +/- antibiotic).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Peripheral Arterial Disease (PAD)
• Meet at least 2 of the following crieria:
• Absence of peripheral pulses at any level on physical examination of lower extremities
• Ankle pressure of 50-90 mmHg
• Finger pressure 30-70 mmHg
• Ankle-branchial index (ABI) 0.5-0.9
• Finger-arm index (FIBI) 0.3-0.7
• Transcutaneous oxygen pressure (TcPO2) 30-59 mmHg
• Degree of infection of the lesion on IDSA/IWGDF scale not greater than 1
• Availability of observation during the study period
• Properly completed patient informed consent

You may not qualify if:

• Ulcers grade 3 or higher
• 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 treatment 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 acetylsalicilic acid)
• Pregnancy or women of chilbearig age not taking effective contraceptive measures. These methods are, according to recommendations of the Clinical Trial Facilitation Group (CTFG) Contraception Working Group (CTFG) (V1.1), the following Hormonal contraception associated with ovulation inhibition, intrauterine decide (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

Sponsors & Collaborators

• Biotechnology Institute IMASD: lead
• Hospital de Basurto: collaborator

Study Sites (1)

Hospital Universitario de Basurto.

Bilbao, Bizkaia, 48013, Spain

RECRUITING

MeSH Terms

Conditions

Foot Ulcer

Interventions

Intercellular Signaling Peptides and Proteins; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Aitana Sainz

CONTACT

+34 945 160 653; aitana.sainz@bti-implant.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: May 1, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

ES (1)