NCT07096830

Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing

Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing: Insights From a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Fazeelat Bibi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Wound Care

Interventions

Type	Name	Description
DRUG	Topical Tetrachlorodecaoxide (TCDO/Oxoferin)	Topical Tetrachlorodecaoxide (TCDO), a solution with antimicrobial and oxygen-releasing properties, will be applied once daily to the wound bed for 21 consecutive days or until satisfactory healing.
OTHER	Standard Wound Care	Standard wound care includes saline irrigation, wound debridement, antibiotic administration as necessary, and sterile dressing. Provided to all participants.

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-07-30
• Completion: 2026-08-30
• First posted: 2025-07-31
• Last updated: 2025-08-05

Locations

1 site across 1 country: Pakistan