CTRI

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CTRI Number

CTRI/2026/03/105435 [Registered on: 05/03/2026] Trial Registered Prospectively

Last Modified On:

04/03/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Medical Device

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study to see if a sleeve that continuously gives oxygen to a wound helps it heal better than regular wound dressings in hospitalized patients.

Scientific Title of Study

DEVELOPMENT AND EVALUATION OF AN OXYGEN DELIVERY SYSTEM FOR ENHANCED WOUND HEALING IN HOSPITAL WARD SETTINGS

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
nil	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dwaarakesh M S
Designation	Postgraduate resident doctor
Affiliation	Department of general surgery, Saveetha medical college hospital and research centre
Address	1a, Casablanca, No. 2 South mada street, Srinagar colony, Saidapet, Chennai. Chennai TAMIL NADU 600015 India
Phone	9962604302
Fax
Email	msdwarak@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Khalilur Rahman A
Designation	Professor
Affiliation	Dept of General surgery, Saveetha medical college hospital and research centre
Address	2nd floor, Department of general surgery, Saveetha medical college hospital and research centre, Thandalam, Chennai. Chennai TAMIL NADU 602105 India
Phone	9962604302
Fax
Email	dr.khalil09@gmail.com

Details of Contact Person
Public Query

Name	Dwaarakesh M.S
Designation	Postgraduate resident doctor
Affiliation	SAVEETHA MEDICAL COLLEGE AND HOSPITAL
Address	1a, Casablanca, No. 2 South mada street, Srinagar colony, Saidapet, Chennai. Chennai TAMIL NADU 600015 India
Phone	9962604302
Fax
Email	MSDWARAK@GMAIL.COM

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dwaarakesh MS
Address	1a, Casablanca, No. 2 South mada street, Srinagar colony, Saidapet, Chennai.
Type of Sponsor	Other [SELF-SPONSORED ]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR DWAARAKESH	SAVEETHA MEDICAL COLLEGE AND HOSPITAL	Floor 2, Department of General Surgery, SAVEETHA MEDICAL COLLEGE AND HOSPITAL, SAVEETHA NAGAR, THANDALAM, CHENNAI - 602105 Chennai TAMIL NADU	9962604302 MSDWARAK@GMAIL.COM

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SAVEETHA MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: L979\|\|Non-pressure chronic ulcer of unspecified part of lower leg,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Continuous Topical Oxygen Delivery Sleeve	Participants randomized to the intervention arm will receive continuous topical oxygen therapy using a limb-enclosing oxygen delivery sleeve connected to a hospital oxygen source, administered in addition to standard wound care. Standard wound care includes wound cleaning, appropriate dressing, infection control, and offloading when indicated. Therapy will be continued as per protocol with weekly wound assessment until complete closure or completion of 8 weeks of follow-up
Comparator Agent	Standard Wound Care	Participants randomized to the comparator arm will receive standard wound care alone, including wound cleaning, dressing, infection control, and offloading as clinically indicated, with weekly assessments for up to 8 weeks or until wound closure.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	Adults aged 18 years and above. Patients with hypoxic wounds of any duration. Swab negative acute surgical wounds. Wound size between 1 cm2 and 20 cm2 after appropriate debridement. Adequate limb perfusion deemed clinically acceptable by the investigator. Wounds suitable for topical therapy without immediate need for surgical closure. Ability and willingness to provide written informed consent. Willingness to comply with study procedures and attend scheduled follow-ups.

ExclusionCriteria

Details

Critical limb ischemia or patients requiring urgent vascular intervention.
Malignant wounds.
Untreated osteomyelitis or severe soft tissue infection requiring immediate surgical management.
Wounds with exposed major blood vessels, nerves, or organs where topical therapy may be unsafe.
Severe uncontrolled systemic illness likely to impair wound healing e.g., advanced renal failure, severe hepatic disease, uncontrolled sepsis.
Known hypersensitivity to materials used in study dressings.
Pregnant or lactating women.
Patients currently enrolled in another interventional clinical trial or who have participated in one within the previous 3 months.
Any condition which, in the opinion of the investigator, makes the participant unsuitable for inclusion.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Percentage reduction in wound area from baseline to 12 weeks measured using digital planimetry.	Percentage reduction in wound area from baseline to 12 weeks measured using digital planimetry.

Secondary Outcome

Outcome	TimePoints
Time to complete wound closure within the 12-week study period.	Measured from date of randomization until complete epithelialization of the wound, assessed up to 12 weeks.
Feasibility of device use in routine ward settings with potential use in low resource centers	Assessed throughout the 12-week study period.

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

16/03/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Chronic and hypoxic wounds are associated with delayed healing, increased risk of infection, and significant healthcare burden. Adequate oxygenation plays a critical role in collagen synthesis, angiogenesis, and bacterial defense, all of which are essential for effective wound repair.

This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of a continuous topical oxygen delivery sleeve as an adjunct to standard wound care. A total of 100 eligible participants will be randomized into intervention and comparator groups to receive either continuous topical oxygen therapy with standard dressing or standard wound care alone.

Wound healing will be assessed using percentage reduction in wound area measured through digital planimetry over a 12-week follow-up period. Secondary outcomes include early wound healing response, time to complete epithelialization, and feasibility of device use in routine ward settings and potential use in low resource ward setting.

The device is designed to utilize oxygen from existing hospital ward supply systems, enabling potential applicability in resource-constrained and low socioeconomic healthcare settings where access to advanced wound care technologies may be limited.

The findings of this study aim to generate clinical evidence supporting accessible, physiologically targeted, and scalable approaches to wound management.