Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing

NCT07096830 | Not Yet Recruiting

• 1 other identifier: KTH-RCT-TCDO-WOUND-2025-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Wound Care

Outcome Measures

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.

  Baseline to 4 weeks

Secondary Outcomes (5)

• Time to 50% wound closure

  Baseline to 12 weeks

• 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

Study Arms (2)

TCDO + Standard Wound Care

EXPERIMENTAL

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.

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

Standard Wound Care Only

ACTIVE COMPARATOR

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.

Other: Standard Wound Care

Interventions

Topical Tetrachlorodecaoxide (TCDO/Oxoferin) DRUG

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.

TCDO + Standard Wound Care

Standard Wound Care OTHER

Standard wound care includes saline irrigation, wound debridement, antibiotic administration as necessary, and sterile dressing. Provided to all participants.

Standard Wound Care Only; TCDO + Standard Wound Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fazeelat Bibi: lead

Study Sites (1)

Khyber Teaching Hospital, MTI KTH Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (1)

• 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 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

tetrachlorodecaoxide

Central Study Contacts

Fazeelat Bibi, MBBS, MRCS part A

CONTACT

+923059501376; fazeelat5740@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General surgery resident, Khyber Teaching Hospital MTI-KTH Peshawar

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)