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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.).
干预措施: Topical application of Plasma Rich in Growth Factors (PRGF) (Drug)
Conventional treatment with adequate offloading and metabolic control, +/- antibiotic).
Manufacturer: N/A
干预措施: Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic). (Procedure)
结局指标
主要结局
Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months
时间窗: 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.
次要结局
- 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)(3 and 6 months follow up)
- Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months(Baseline and three months follow up)
- Assessment of amputation risk as measured by the WIfI scale at baseline, 3 and 6 months(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)(Baseline, 3 and 6 months follow up)
- 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(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(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.(Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment))