Chronic Wound CareTCDO-WoundNCT07096830
Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing
A study testing Topical Tetrachlorodecaoxide (TCDO/Oxoferin) and Standard Wound Care in people with Chronic Wound Care, run by Fazeelat Bibi at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wound Care
- What is being tested?
- Topical Tetrachlorodecaoxide (TCDO/Oxoferin) and Standard Wound Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients receiving immunosuppressive therapy or corticosteroids
- Presence of malignancy
- Patients who do not provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Khyber Teaching Hospital, MTI KTH Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
Fazeelat Bibi, MBBS, MRCS part A, +923059501376, fazeelat5740@gmail.com
About this study
Official title: Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing: Insights From a Randomized Controlled 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.
Read the 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
- Being tested
- Topical Tetrachlorodecaoxide (TCDO/Oxoferin), Standard Wound Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard Wound CareOther
Standard wound care includes saline irrigation, wound debridement, antibiotic administration as necessary, and sterile dressing. Provided to all participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 weeks
Secondary outcomes (5)
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.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
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.
Measured: Base line to 12 weeks
Change in wound-related quality of life (Wound-QoL) score
The impact of chronic wounds on patients' quality of life will be assessed using the validated Wound-Related Quality of Life (Wound-QoL) questionnaire. The Wound-QoL consists of 17 items, each scored from 0 to 4, resulting in a total score ranging from 0 (no impairment) to 68 (maximum impairment). Higher scores indicate worse quality of life. Scores will be measured at baseline and follow-up visits, and changes over time will be analyzed.
Measured: Base line to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Wound CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fazeelat Bibi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fazeelat Bibi, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096830
- Sponsor's protocol ID
- KTH-RCT-TCDO-WOUND-2025-01
- Acronym
- TCDO-Wound
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27689045
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing: Insights From a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07096830
- Acronym / sponsor ID
- TCDO-Wound / KTH-RCT-TCDO-WOUND-2025-01
- Conditions
- Chronic Wound Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fazeelat BibiUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCDO + Standard Wound Care | Experimental | Drug: Topical Tetrachlorodecaoxide (TCDO/Oxoferin), Other: Standard Wound CareParticipants 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. |
| Standard Wound Care Only | Active comparator | Other: Standard Wound CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients receiving immunosuppressive therapy or corticosteroids
- Presence of malignancy
- Patients who do not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | TCDO + Standard Wound Care |
| Standard Wound CareStandard wound care includes saline irrigation, wound debridement, antibiotic administration as necessary, and sterile dressing. Provided to all participants. | Other | Standard Wound Care Only, TCDO + Standard Wound Care |
Primary outcome
Change in wound area (cm²)
Time frame: Baseline to 4 weeks
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 27689045Parikh 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Tetrachlorodecaoxide (TCDO/Oxoferin) and Standard Wound Care in people with Chronic Wound Care, run by Fazeelat Bibi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fazeelat Bibi, MBBS, MRCS part A (+923059501376, fazeelat5740@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound area (cm²) (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07096830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.