Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing
ConditionChronic Wound Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFazeelat Bibi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults > 18 years diagnosed with chronic wounds (duration > 6 weeks)
Wound size between 5 and 10 cm²
Ankle-Brachial Pressure Index (ABPI) > 0.8 for venous leg ulcers
Palpable pulses for diabetic foot ulcers
Disqualifiers
Patients receiving immunosuppressive therapy or corticosteroids
Presence of malignancy
Patients who do not provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Topical Tetrachlorodecaoxide (TCDO/Oxoferin)
DrugTopical 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.
Standard Wound Care
Other interventionStandard wound care includes saline irrigation, wound debridement, antibiotic administration as necessary, and sterile dressing. Provided to all participants.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: TCDO + Standard Wound CareExperimental treatment 2 interventions
Group B: Standard Wound Care OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in wound area (cm²)
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.
Time frame
Baseline to 4 weeksSecondary outcomes
1
Time to 50% wound closure
Time (in days) required to achieve 50% reduction in wound area from the baseline measurement. Wound size will be assessed using the simple ruler method by multiplying the longest length and the widest perpendicular width. This outcome serves as an early indicator of treatment efficacy.
Time frame
Baseline to 12 weeks2
Change in pain score (Visual Analog Scale, VAS)
Change in wound-related pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Pain scores will be recorded at baseline and during follow-up visits to evaluate change in pain score over time.
Time frame
Baseline to 12 weeks3
Incidence of wound infection
Incidence of clinical wound infection, determined by the presence of local signs of inflammation (e.g., redness, swelling, warmth), purulent discharge, or the need for antibiotic therapy as judged by the treating clinician.
Time frame
Baseline to 12 weeks4
Cost-Effectiveness of TCDO Treatment
Total treatment cost per patient will be compared between the intervention and control groups. Costs will include expenses related to wound dressings, hospital visits, medications, and other wound management components. This analysis will help determine the economic feasibility of using TCDO in resource-limited settings.
Time frame
Base line to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fazeelat Bibi
Lead sponsor
Khyber Teaching Hospital
Sponsor institution
Source ClinicalTrials.gov
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