Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing: Insights From a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in wound area (cm²)
研究概览
简要总结
This is a single-center, randomized controlled trial evaluating the effectiveness of topical tetrachlorodecaoxide (TCDO) solution in enhancing chronic wound healing. The study will compare standard wound care with and without the addition of topical TCDO drops. Eligible adult participants with chronic wounds of more than six weeks' duration will be randomly assigned to either the intervention or control group. The trial aims to assess the rate of wound healing, time to 50% wound closure, pain reduction measured by the Visual Analog Scale (VAS), and cost-effectiveness.
详细描述
Chronic wounds-including diabetic foot ulcers, arterial ulcers, venous leg ulcers, and pressure ulcers-represent a major clinical and economic burden in low-resource settings. Delayed healing increases the risk of infection, amputation, and prolonged hospitalization. Various topical agents have been used to enhance healing, with variable success. Tetrachlorodecaoxide (TCDO), a solution with antimicrobial and oxygen-releasing properties, has shown promising results in promoting granulation tissue. However, local clinical evidence is limited.
This randomized controlled trial aims to evaluate the effectiveness of topical tetrachlorodecaoxide (TCDO) in promoting chronic wound healing, compared to standard wound care alone. A total of 66 participants with chronic wounds (duration ≥ 6 weeks) will be enrolled in the Department of General Surgery, MTI Khyber Teaching Hospital (MTI-KTH), Peshawar. Participants will be randomly assigned to one of two groups: an intervention group receiving standard wound care plus topical TCDO application, or a control group receiving standard wound care alone. TCDO will be applied once daily (OD) for up to three weeks. Patients will be followed for up to 12 weeks to assess healing progress.
The primary outcome will be the percentage reduction in wound area, measured using the simple ruler method. Secondary outcomes include time to 50% wound closure, change in pain score using the Visual Analog Scale (VAS), wound Quality of Life (QoL) scores, and a cost-effectiveness analysis. Safety outcomes will be monitored throughout the study.
Ethical approval will be obtained from the MTI-KTH Institutional Review Board (IRB). The study will be conducted free of cost to participants and may offer an affordable treatment alternative to improve chronic wound care in resource-limited settings.
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
- 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
- •Adults > 18 years diagnosed with chronic wounds (duration > 6 weeks)
- •Wound size between 5 and 10 cm²
- •Adequate perfusion:
- •Ankle-Brachial Pressure Index (ABPI) > 0.8 for venous leg ulcers
- •Palpable pulses for diabetic foot ulcers
排除标准
- •Patients receiving immunosuppressive therapy or corticosteroids
- •Presence of malignancy
- •Patients who do not provide informed consent
研究组 & 干预措施
TCDO + Standard Wound Care
Participants in this group will receive topical Tetrachlorodecaoxide (TCDO, also known as Oxoferin®) drops applied directly to the wound bed once daily for 21 consecutive days, or until satisfactory healing is achieved. This will be administered alongside standard wound care practices, including saline irrigation, wound debridement, antibiotics as necessary, and sterile dressing.
干预措施: Topical Tetrachlorodecaoxide (TCDO/Oxoferin) (Drug)
TCDO + Standard Wound Care
Participants in this group will receive topical Tetrachlorodecaoxide (TCDO, also known as Oxoferin®) drops applied directly to the wound bed once daily for 21 consecutive days, or until satisfactory healing is achieved. This will be administered alongside standard wound care practices, including saline irrigation, wound debridement, antibiotics as necessary, and sterile dressing.
干预措施: Standard Wound Care (Other)
Standard Wound Care Only
Participants in this group will receive standard wound care practices, including saline irrigation, wound debridement, antibiotics as necessary, and sterile dressing, without the use of TCDO.
干预措施: Standard Wound Care (Other)
结局指标
主要结局
Change in wound area (cm²)
时间窗: Baseline to 4 weeks
Wound area will be measured weekly using the simple ruler method by multiplying the longest length and the widest perpendicular width with a sterile ruler. The change in wound size from baseline to 4 weeks will be used to assess healing progress. A decrease in wound area will indicate improvement.
次要结局
- Change in pain score (Visual Analog Scale, VAS)(Baseline to 12 weeks)
- Incidence of wound infection(Baseline to 12 weeks)
- Cost-Effectiveness of TCDO Treatment(Base line to 12 weeks)
- Change in wound-related quality of life (Wound-QoL) score(Base line to 12 weeks)
- Time to 50% wound closure(Baseline to 12 weeks)
研究者
Fazeelat Bibi
General surgery resident, Khyber Teaching Hospital MTI-KTH Peshawar
Khyber Teaching Hospital