- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07373327
Vinegar vs Normal Saline Dressing for Diabetic Foot Ulcers
A Randomized Clinical Trial to Compare the Efficacy of Vinegar Dressing Versus Normal Saline Dressing in the Treatment of Diabetic Foot Ulcers
This study is investigating the effectiveness of two different types of wound dressings in treating diabetic foot ulcers (DFUs), a common complication of diabetes that can be difficult to heal. The study will compare the use of vinegar dressings to normal saline (saltwater) dressings to see which one helps heal the wound faster and more effectively.
People with diabetic foot ulcers often struggle with infections and slow healing. The goal of this study is to determine if vinegar, a simple and affordable treatment, works better than saline in improving wound healing and reducing infections. The study will measure how quickly the wound heals, how much dead tissue is removed, and whether the bacteria in the wound disappear.
This study will involve patients with infected diabetic foot ulcers. Participants will be randomly assigned to receive either vinegar or saline dressing. The results will help determine the best and most cost-effective treatment for diabetic foot ulcers, potentially making it easier for patients to access better care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. MIAN MUHAMMAD BILAL Principal Investigator
- Phone Number: 03451110281
- Email: drbilal279@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: 20 to 65 years.
- Gender: Both male and female participants are included.
- Condition: Patients with Grade 3 and 4 infected diabetic foot ulcers (DFU) according to the Wagner classification.
Exclusion Criteria:
- Wagner Grades 1, 2, 5, and 6 diabetic foot ulcers.
- History of Radiotherapy.
- History of Chemotherapy.
- Use of Steroids.
- Use of Immunosuppressive drugs.
- Allergy to vinegar.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vinegar Dressing
|
In this arm, participants will receive a dressing made by soaking gauze in a vinegar solution.
The solution will be prepared by adding one tablespoon of plain white vinegar to a cup of normal saline.
The gauze will be applied to the wound in a wet-to-dry manner, twice daily, until the wound is fully healed or cultured negative.
The goal is to assess the effectiveness of vinegar in promoting wound healing, reducing infection, and removing necrotic tissue.
|
|
Active Comparator: Normal Saline Dressing
|
In this arm, participants will receive a dressing using normal saline (saltwater).
The wound will be washed with normal saline and dressed in a wet-to-dry manner, twice daily, until the wound is fully healed or cultured negative.
This arm will serve as the control group, with the goal of comparing the outcomes of saline dressing to vinegar dressing in terms of wound healing, bacterial infection reduction, and necrotic tissue removal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Negative Cultures
Time Frame: From enrollment to 8 weeks after treatment initiation
|
Definition: The proportion of participants whose wound cultures become negative (no bacterial growth) by the end of the treatment period (e.g., 3 weeks or 8 weeks). Measurement: The swab cultures will be taken weekly, and the presence or absence of bacterial infection will be recorded until the wound is culture-negative. Rationale: This outcome is crucial as it directly measures the effectiveness of vinegar dressing in reducing wound infection compared to normal saline dressing. |
From enrollment to 8 weeks after treatment initiation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Exp133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcer (DFU)
-
PolarityTETemporarily not availableNeuropathic Diabetic Ulcer - Foot | Diabetic Foot Disease | DFU
-
DEBx Medical B.V.Not yet recruitingDiabetic Foot Wounds | Diabetic Foot Ulcer (DFU) | Diabetic Foot Ulcer Treatment
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StimLabsNot yet recruitingDiabetic Foot | Foot Ulcer | Ulcer Foot | Diabetic Foot Ulcer (DFU)
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Libyan Center for Biotechnology ResearchNot yet recruiting
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United Medical and Dental CollegeCenter for Bioequivalence Studies and Clinical ResearchRecruitingDiabetic Foot Ulcer (DFU)Pakistan
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Royal BiologicsRecruitingDiabetic Foot Ulcer (DFU) | Amnio-MaxxUnited States
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Applied Biologics, LLCSerena GroupRecruitingUlcer | Diabetic Foot Ulcer | Diabetic Foot Ulcers (DFU) | Foot Ulcer ChronicUnited States
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Ayu, Inc.MCRARecruitingDiabetic Foot Ulcer (DFU) | Granulation of Chronic Diabetic WoundsUnited States
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