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

NCT06356480 | Completed Phase 1 DMC

• 1 other identifier: 266
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Granulation of Chronic Diabetic Wounds; Diabetic Wounds

Keywords

Diabetic wounds, 1% acetic acid, epithelialization

Outcome Measures

Primary Outcomes (1)

• Early epithelialization and granulation

  After selection of the patients adequate antibiotics were given as per standard hospital protocol. Patients were assessed for application of 1% acetic acid dressing after every 12 hours for early epithelialization and granulation which will be diagnosed clinically by examining the wound respectively.

  at 48 hours, 72 hours and 07 days

Study Arms (2)

1% acetic acid dressing in chronic diabetic wounds

EXPERIMENTAL

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

Biological: 1% Acetic acid dressing

Normal saline soaked dressing in chronic diabetic wounds

NO INTERVENTION

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

Interventions

1% Acetic acid dressing BIOLOGICAL

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

1% acetic acid dressing in chronic diabetic wounds

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Muhammad Naeem: lead

Study Sites (1)

Pak Emirates military hospital

Rawalpindi, Punjab Province, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the department of surgery

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 10, 2024
• Study Start: October 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

PA (1)