Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical Tetrachlorodecaoxide (TCDO/Oxoferin), Standard Wound Care.
- Who it may be relevant to
- Registry conditions: Chronic Wound Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing: Insights From a Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in wound area (cm²) [Time frame: Baseline to 4 weeks]
Secondary outcome measures (5)
- Time to 50% wound closure [Time frame: Baseline to 12 weeks]
- Change in pain score (Visual Analog Scale, VAS) [Time frame: Baseline to 12 weeks]
- Incidence of wound infection [Time frame: Baseline to 12 weeks]
- Cost-Effectiveness of TCDO Treatment [Time frame: Base line to 12 weeks]
- Change in wound-related quality of life (Wound-QoL) score [Time frame: Base line to 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Khyber Teaching Hospital, MTI KTH Peshawar — Peshawar
Publications
- Parikh R, Bakhshi G, Naik M, Gaikwad B, Jadhav K, Tayade M. The Efficacy and Safety of Tetrachlorodecaoxide in Comparison with Super-oxidised Solution in Wound Healing. Arch Plast Surg. 2016 Sep;43(5):395-401. doi: 10.5999/aps.2016.43.5.395. Epub 2016 Sep 21. PMID 27689045
Identifiers
NCT: NCT07096830 · KTH-RCT-TCDO-WOUND-2025-01