1% Acetic Acid vs Normal Saline Dressing inManagement of Diabetic Foot

NCT ID: NCT06356480

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-04-30

Brief Summary

Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic diabetic wounds

Detailed Description

Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic wounds. They pose a major challenge that is cumbersome in terms of wound healing and also add to the cost in terms of quality of life to the patient and is a financial burden for the hospitals. Three main factors have been found to be the causative factors for the development of a chronic wound: firstly, bacterial colonisation or commonly called bioburden; secondly, reperfusion injury; and thirdly, cellular and systemic factors. Most of the wounds if not all of them are contaminated with pathogenic microorganisms, but this itself does not affect the healing of wounds. When the contamination increases to a point of critical colonisation or infection, then the infection or the bioburden in the wound becomes a major contributing factor that impedes wound healing. Chronic wounds do not progress to the proliferative phase of wound healing and undergo a detention in the inflammatory phase of healing because of which there is a continuous influx of neutrophils into the wound area, with the release of free radicals, cytolytic enzymes and inflammatory mediators that cause damage to the invading pathogens as well as to the host tissue. Poor blood supply results in hypoxic conditions in tissues, which can lead to cell death and tissue necrosis. This provides good growing conditions for pathogenic microorganisms leading to the establishment and colonisation of bacteria in the host tissue.

Conditions

Granulation of Chronic Diabetic Wounds; Diabetic Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1% acetic acid dressing in chronic diabetic wounds

1% Acetic acid dressing in chronic diabetic wounds twice daily along with oral antibiotics to see the early epithelialization of the wounds

Group Type: EXPERIMENTAL

1% Acetic acid dressing

Intervention Type: BIOLOGICAL

1% acetic acid dressing in chronic diabetic foot and wounds to see early epithelialization and later on graft application.

Normal saline soaked dressing in chronic diabetic wounds

Normal Saline soaked dressing in chronic diabetic wounds along with antibiotics to see early epithelialization over diabetic wounds

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

1% Acetic acid dressing

1% acetic acid dressing in chronic diabetic foot and wounds to see early epithelialization and later on graft application.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Chronic diabetic wounds
• All gender
• age 40-65 years

Exclusion Criteria

• Chronic wounds due to trauma, neoplasm, burn
• peripheral vascular disease
• Osteomyelitis grade 3 and above.

Data collection:

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Muhammad Naeem

OTHER

Sponsor Role: lead

Responsible Party

Dr. Muhammad Naeem

Head of the department of surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Pak Emirates military hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

266

Identifier Type: -

Identifier Source: org_study_id