Foot Ulcers, DiabeticPhase 4PIEDIABETICONCT06952998
Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease
A Phase 4 study testing Topical application of Plasma Rich in Growth Factors (PRGF) in people with Foot Ulcers, Diabetic, run by Biotechnology Institute IMASD at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcers, Diabetic
- What is being tested?
- Topical application of Plasma Rich in Growth Factors (PRGF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2025to 30 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Basurto.
Bilbao, Bizkaia, 48013
Arkaitz Lara, 944006000, arkaitz.laraquintana@osakidetza.eus
About this study
Official 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
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
- Being tested
- Topical application of Plasma Rich in Growth Factors (PRGF), Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: Drug: Topical application of Plasma Rich in Growth Factors (PRGF) |
| Conventional treatment with adequate offloading and metabolic control, +/- antibiotic). | Active comparator | Manufacturer: N/A Receives: Procedure: Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months follow up
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 3 and 6 months follow up
Evaluation of wound closure time
Evaluation of wound closure time
Measured: 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
Measured: 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
Measured: 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.
Measured: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcers, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotechnology Institute IMASD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital de Basurto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952998
- Sponsor's protocol ID
- BTIIMD-01-EC-23-PIEDIABETICO
- Acronym
- PIEDIABETICO
- Status last verified
- Sep 2025
- First submitted
- 26 Mar 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06952998
- Acronym / sponsor ID
- PIEDIABETICO / BTIIMD-01-EC-23-PIEDIABETICO
- Conditions
- Foot Ulcers, Diabetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Biotechnology Institute IMASDIndustry (pharma, biotech, devices)
- Collaborators
- Hospital de Basurto
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical application of Plasma Rich in Growth Factors (PRGF) | Experimental | Drug: 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.). |
| Conventional treatment with adequate offloading and metabolic control, +/- antibiotic). | Active comparator | Procedure: Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).Manufacturer: N/A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Topical application of Plasma Rich in Growth Factors (PRGF) |
| 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). | Procedure or surgery | Conventional treatment with adequate offloading and metabolic control, +/- antibiotic). |
Primary outcome
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: 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.
9 secondary outcomes
Change in ulcer size at three and six months (percent) (area and depth)
Time frame: 3 and 6 months follow up
Frequency of ulcers with complete closure at three and six months (percent)
Time frame: 3 and 6 months follow up
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
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
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
Evaluation of wound closure time
Time frame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical application of Plasma Rich in Growth Factors (PRGF) in people with Foot Ulcers, Diabetic, run by Biotechnology Institute IMASD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aitana Sainz (+34 945 160 653, aitana.sainz@bti-implant.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months (time frame: 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.