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NCT Number: NCT06952998

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.

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Key information

Conditions

Foot Ulcers, Diabetic Foot Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Basurto.

Bilbao, Bizkaia, 48013, Spain

Location status: Recruiting

Location contact

Arkaitz Lara

CONTACT

[email protected]

944006000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

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

    Time frame: 6 months follow up

    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.

Secondary outcomes

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

    Time frame: 3 and 6 months follow up

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

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

    Time frame: 3 and 6 months follow up

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

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

    Time frame: Baseline and three months follow up

    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.

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

    Time frame: Baseline, 3 and 6 months follow up

    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.

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

    Time frame: Baseline, 3 and 6 months follow up

    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

  6. Evaluation of wound closure time

    Time frame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)

    Evaluation of wound closure time

  7. Safety endpoint. Incidence and type of adverse events

    Time frame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)

    Incidence and type of adverse events

  8. Safety endpoint. Presence of infetion at three and six months assessed with the IWGDF/IDSA classification

    Time frame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)

    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

  9. Safety endpoint. Frequancy and type of deficiencies of the medical devices used for PRGF preparation.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aitana Sainz

CONTACT

[email protected]

+34 945 160 653

Sponsors and collaborators

Lead sponsor

Biotechnology Institute IMASD

Industry

Collaborators

  • Hospital de Basurto

Registry information

Official study title

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

Acronym: PIEDIABETICO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 1, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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