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

Randomized Clinical Trial, Controlled With Conventional Treatment to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Foot Ulcers, Diabetic
• Intervention / Treatment: Drug: Topical application of Plasma Rich in Growth Factors (PRGF); Procedure: Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aitana Sainz; Phone Number: +34 945 160 653; Email: aitana.sainz@bti-implant.es

Study Locations

• Spain
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48013
      • Recruiting
      • Hospital Universitario de Basurto.
      • Contact: Arkaitz Lara; Phone Number: 944006000; Email: arkaitz.laraquintana@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical application of Plasma Rich in Growth Factors (PRGF); 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); 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).
Active Comparator: Conventional treatment with adequate offloading and metabolic control, +/- antibiotic).; Manufacturer: N/A	Procedure: Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Injury dimensions; Depth/tissues affected; Edges; Type of tissue in the wound bed; Exudate; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ulcer size at three and six months (percent) (area and depth)	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)	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	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.	Baseline and three months follow up
Assessment of amputation risk as measured by the WIfI scale at baseline, 3 and 6 months	The Wound, Ischemia, and foot Infection (WIfI) classification system assesses limb threat in three domains. Wound is graded 0-3 based on ulcer depth, extent, gangrene, and pain. Ischemia is graded 0-3 using ankle-brachial index, transcutaneous oxygen pressure, and toe pressure. Infection is graded 0-3 using adapted criteria from the IDSA and PEDIS systems. Each domain's score reflects severity, aiding in amputation risk and treatment planning.	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)	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS ranges from 0 (the worst health you can imagine) to 100 (the best health you can imagine), where higher scores represent better health outcomes	Baseline, 3 and 6 months follow up
Evaluation of wound closure time	Evaluation of wound closure time	Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
Safety endpoint. Incidence and type of adverse events	Incidence and type of adverse events	Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
Safety endpoint. Presence of infetion at three and six months assessed with the IWGDF/IDSA classification	International Working Group on the Diabetic Foot (IWGDF) infectious diseases society of America (IDSA). Minimum Value: 1 (o "No Infection") Maximum Value: 4 (o "Severe Infection") Higher scores mean: Worse outcomes	Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
Safety endpoint. Frequancy and type of deficiencies of the medical devices used for PRGF preparation.	Safety endpoint. Frequancy and type of deficiencies of the medical devices used for PRGF preparation.	Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)

Collaborators and Investigators

• Sponsor: Biotechnology Institute IMASD
• Collaborators: Hospital de Basurto

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Leg Ulcer; Foot Diseases; Skin and Connective Tissue Diseases; Foot Ulcer; Anti-Infective Agents; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Biological Factors; Anti-Bacterial Agents; Intercellular Signaling Peptides and Proteins
• Other Study ID Numbers: BTIIMD-01-EC-23-PIEDIABETICO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No