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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06356480
Other study ID # 266
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 1, 2023
Est. completion date April 2024

Study information

Verified date April 2024
Source Pak Emirates Military Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 74
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Pak Emirates military hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Dr. Muhammad Naeem

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT00815217 - The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers N/A