CTIS2023-504275-24-01进行中（未招募）1 期
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. - BTIIMD-01-EC-23-PIED
Biotechnology Institue I Mas D S.L.0 个研究点目标入组 38 人开始时间: 2024年2月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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 criteria: ? 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-brachial 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 treatments 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 acetylsalicylic acid) - Pregnancy or women of childbearing age not taking effective contraceptive measures as outlined in CTFG Recommendations related to contraception and pregnancy testing in clinical trials V 1. - Breastfeeding women - Treatment with monoclonal antibodies - Any inabilities to participate in the study
研究者
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