Granulation of Chronic Diabetic WoundsPhase 1/2NCT06356480
1% Acetic Acid vs Normal Saline Dressing inManagement of Diabetic Foot
A Phase 1/2 study testing 1% Acetic acid dressing in people with Granulation of Chronic Diabetic Wounds and Diabetic Wounds, run by Dr. Muhammad Naeem at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Granulation of Chronic Diabetic Wounds, Diabetic Wounds
- What is being tested?
- 1% Acetic acid dressing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Apr 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic diabetic wounds
- All gender
- age 40-65 years
Who cannot join
- Chronic wounds due to trauma, neoplasm, burn
- peripheral vascular disease
- Osteomyelitis grade 3 and above.
- Data collection:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RANDOMIZED CONTROL TRIAL TO COMPARE 1% ACETIC ACID DRESSING VS SALINE DRESSING TO SEE EARLY WOUND HEALING IN DIABETIC WOUNDS.
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
Read the 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.
- Being tested
- 1% Acetic acid dressing
- Keywords
- Diabetic wounds, 1% acetic acid, epithelialization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Acetic acid dressingBiological
1% acetic acid dressing in chronic diabetic foot and wounds to see early epithelialization and later on graft application.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 48 hours, 72 hours and 07 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulation of Chronic Diabetic WoundsStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Muhammad Naeem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Muhammad Naeem, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356480
- Sponsor's protocol ID
- 266
- Status last verified
- Apr 2025
- First submitted
- 22 Mar 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED CONTROL TRIAL TO COMPARE 1% ACETIC ACID DRESSING VS SALINE DRESSING TO SEE EARLY WOUND HEALING IN DIABETIC WOUNDS.
- ClinicalTrials.gov ID
- NCT06356480
- Acronym / sponsor ID
- 266
- Keywords
- Diabetic wounds, 1% acetic acid, epithelialization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Dr. Muhammad NaeemUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Apr 2024 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% acetic acid dressing in chronic diabetic wounds | Experimental | Biological: 1% Acetic acid dressing1% Acetic acid dressing in chronic diabetic wounds twice daily along with oral antibiotics to see the early epithelialization of the wounds |
| 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic diabetic wounds
- All gender
- age 40-65 years
Key exclusion criteria (4 listed)
- Chronic wounds due to trauma, neoplasm, burn
- peripheral vascular disease
- Osteomyelitis grade 3 and above.
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 |
|---|---|---|
| 1% Acetic acid dressing1% acetic acid dressing in chronic diabetic foot and wounds to see early epithelialization and later on graft application. | Biological | 1% acetic acid dressing in chronic diabetic wounds |
Primary outcome
Early epithelialization and granulation
Time frame: at 48 hours, 72 hours and 07 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 1% Acetic acid dressing in people with Granulation of Chronic Diabetic Wounds and Diabetic Wounds, run by Dr. Muhammad Naeem 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 Apr 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early epithelialization and granulation (time frame: at 48 hours, 72 hours and 07 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.