Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing (TCDO-Wound)

Fazeelat Bibi

Status: Not yet enrolling

Conditions: Chronic Wound Care

Treatments: Other: Standard Wound Care; Drug: Topical Tetrachlorodecaoxide (TCDO/Oxoferin)

Study type: Interventional

Funder types: Other

Identifiers

NCT07096830

KTH-RCT-TCDO-WOUND-2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients receiving immunosuppressive therapy or corticosteroids
• Presence of malignancy
• Patients who do not provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

TCDO + Standard Wound Care

Experimental group

Description:

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.

Treatment:

Drug: Topical Tetrachlorodecaoxide (TCDO/Oxoferin)

Other: Standard Wound Care

Standard Wound Care Only

Active Comparator group

Description:

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.

Treatment:

Other: Standard Wound Care