CTRI/2023/03/050481招募中Unknown
A prospective, open label, non-randomized, comparative, investigator initiated study to evaluate safety and effectiveness of topical application of Autologous Growth Factor Concentrate using Healrex therapy kit with standard wound care in Lower Extremity Diabetic Ulcer
Dr Ketan Vagholkar0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
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
入选标准
- •1 An adult (at least 18 years of age) of any gender with type 1 or 2 diabetes mellitus with controlled blood glucose level
- •2. Patient with a single chronic ulcer of at least one month despite appropriate wound care
- •3. Grade I or II of Maggitt Wagner classification system
- •4. Ulcer size with surface area of =1cm2 =25cm2 after debridement with well controlled infection not requiring skin graft
- •5. Adequate arterial blood supply measured by (color) doppler ultrasonography or palpable pulse of dorsalis pedis / posterior tibial artery
- •6. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing women.
- •7. Patient able and willing to provide informed consent
- •8. Patient able and willing to comply with protocol visits and procedures
排除标准
- •1. Inter digit ulcers or Wound originated from amputation bed
- •2. Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers
- •3. Active ulcer infection assessed by clinical examination and radiography if necessary or Active osteomyelitis affecting the area of the target ulcer (Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement and controlled by standard wound care.)
- •4. Poorly controlled diabetes (uncontrolled glycaemia: HbA1c% = 10%), renal failure (serum creatinine > 2.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL), low platelet count ( < 1,00,000 /dL), hemoglobin levels <10 gm/dl and RBS >200 mg/dL
- •5. Patients who are Hepatitis B or C or HIV or VDRL/RPR positive.
- •6. Known connective tissue or malignant disease or history of severe cerebrovascular events.
- •7. Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy
- •8. Use of investigational drug/device or growth factor within 30 days of screening
- •9. Previous treatment of advanced therapy (other than standard of care) for lower extremity diabetic ulcer including Negative Pressure Wound Therapy (NPWT) device or hyperbaric oxygen or growth factor within 7 days of screening
- •10. Patients with blood dyscrasias, patients on anticoagulants/ antiplatelet or with actively bleeding wounds or hemoglobinopathy
- •11. Pregnancy, Breast feeding, Nursing mother or fertile woman not practicing birth control
- •12. Patients expected to be noncompliant with the protocol or felt to be unsuitable by the Investigator for any other reason.
研究者
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