Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Safety
研究概览
简要总结
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers.
HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and differentiation at the wound area.
- The primary end point of this study is assessment of safety in treating with HO/03/03 and the efficacy of the drug to promote wound closure of chronic wounds.
- The secondary end points are assessment time to closure and healing rate for the measurement of wound healing progression.
详细描述
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers.
Pretreatment phase: During a pretreatment phase that will last up to 14 days, all patients will receive the conventional treatment once a day at the discretion of the investigator. All wounds will be morphologically monitored by photo documentation daily and measurements of wound area once a week.
Initial study visit: patients will begin treatment after completing all necessary demands in pre-treatment phase or after ruling out of all exclusion criteria. All wounds will be cleaned from previous treatment by surgical debridement and irrigation (saline).
Treatment phase: Following the pre-treatment phase, wounds will be treated topically with HO/03/03 for 30 days. During this 30 day phase, patients will receive daily treatments with HO/03/03 either at home by a certified nurse or at the clinic. Wounds will be monitored by certified medical staff member as well as photo documentation. Then application of the treatment followed by a 15-minute rest. Finally wound will be dressed with a fresh dressing and monitoring of any adverse events.
Patients will be administered HO/03/03 in addition to weight off-load Once a week wounds will be monitored by a physician: wounds size will be determined and documented. Patients will be evaluated for pain sensation at the wound area by filling a pain scoring questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 must satisfy all of the following inclusion criteria to be included in the study:
- •be male or female over the age of 18;
- •have a diabetic neuropathic plantar and/or venous ulcer;
- •wound diameter <10cm;
- •wound depth is no more than exposed muscle;
- •have a current physical examination, which reveals no clinically significant abnormalities, except diabetes or diabetic ulcer/wound related condition
- •be available for the entire study period, and be able and willing to adhere to protocol requirements;
- •vascular inflow as measured by Doppler: ABI >= 0.7
- •have a debilitating wound over a period of 1 month prior to the experiment;
- •if female of childbearing potential, must be using a reliable form of birth control;
- •provide written informed consent prior to admission into the study.
排除标准
- •Patients will be excluded from the study if they meet any of the following exclusion criteria:
- •have a body mass index (BMI) > 45;
- •have a glycosylated hemoglobin (HbAlc) > 12.0%;
- •have a history or presence of HIV or a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease;
- •have any clinically significant illness during the 4 weeks prior to admission into the study, except diabetes type1 or type2;
- •patients on concomitant medications that alter blood glucose levels (e.g., ACE inhibitors, lipid lowering agents, etc) must be on a stable dosage regimen for at least 4 weeks prior to entry into the study and the dosage must remain stable throughout the study;
- •patients on chemotherapy;
- •participation in a clinical study or use of an investigational drug within 30 days prior to admission to this study;
- •are pregnant or lactating;
- •visible bone exposure at wound site;
- •have any signs of clinical infection in the wound (which could be linked to raised body temperature), necrosis, erythema or mild drainage;
- •have any acute illness within 2 weeks prior to Screening;
- •residing in a nursing facility and/or are bed-ridden (unable to come to receive treatment at the clinic);
研究组 & 干预措施
Treatment arm
One Arm - Active Compound (HO/03/03)
干预措施: HO/03/03 (Drug)
结局指标
主要结局
Safety
时间窗: Treatment Period
次要结局
- Time to Heal & Rate of Healing(Treatment Period)