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| Name | Class |
|---|---|
| Hospital de Basurto | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.). |
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| Conventional treatment with adequate offloading and metabolic control, +/- antibiotic). | Active Comparator | Manufacturer: N/A |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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:
| 6 months follow up |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aitana Sainz | Contact | +34 945 160 653 | aitana.sainz@bti-implant.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Basurto. | Recruiting | Bilbao | Bizkaia | 48013 | Spain |
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| 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). |
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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) |
| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
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| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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