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

Conditions

Foot ulcers in diabetic patients with peripheral arterial disease

Brief summary

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

Detailed description

- Age - Sex - Toxic habits (tobacco, alcohol) - Body mass index, - Time of evolution - Etiology (Type of diabetes) - Ulcer dimensions (area and depth) - Previous treatments, - Change in ulcer size at three and six months (%) (area and depth) - Frequency of ulcers with complete closure at three and six months (%) - Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months, - Assessment of the severity of the ulcer as measured by the SINBAD scale at baseline, 3 and 6 months. -Assessment of pain and quality of life at baseline, three and six months using the EQ-5D-5L scale - Cost of wound closure, - Incidence and type of adverse events - Presence of infection according to SINBAD criterion 4 at baseline, three and six months - Frequency and type of deficiencies of the medical devices used for PRGF preparation, - Biomarkers involved in tissue damage repair

Related papers

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Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPlasma rich in growth factors

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months	—

Secondary

Measure	Time frame
- Age - Sex - Toxic habits (tobacco, alcohol) - Body mass index, - Time of evolution - Etiology (Type of diabetes) - Ulcer dimensions (area and depth) - Previous treatments, - Change in ulcer size at three and six months (%) (area and depth) - Frequency of ulcers with complete closure at three and six months (%) - Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months, - Assessment of the severity of the ulcer as measured by the SINBAD scale at baseline, 3 and 6 months. -Assessment of pain and quality of life at baseline, three and six months using the EQ-5D-5L scale - Cost of wound closure, - Incidence and type of adverse events - Presence of infection according to SINBAD criterion 4 at baseline, three and six months - Frequency and type of deficiencies of the medical devices used for PRGF preparation, - Biomarkers involved in tissue damage repair	—

Measure

Time frame

- Age - Sex - Toxic habits (tobacco, alcohol) - Body mass index, - Time of evolution - Etiology (Type of diabetes) - Ulcer dimensions (area and depth) - Previous treatments, - Change in ulcer size at three and six months (%) (area and depth) - Frequency of ulcers with complete closure at three and six months (%) - Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months, - Assessment of the severity of the ulcer as measured by the SINBAD scale at baseline, 3 and 6 months. -Assessment of pain and quality of life at baseline, three and six months using the EQ-5D-5L scale - Cost of wound closure, - Incidence and type of adverse events - Presence of infection according to SINBAD criterion 4 at baseline, three and six months - Frequency and type of deficiencies of the medical devices used for PRGF preparation, - Biomarkers involved in tissue damage repair

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Countries

Spain

Outcome results

None listed