NCT07373327

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Expected
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 13, 2026

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of Negative Cultures

    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

Study Arms (2)

Vinegar Dressing

EXPERIMENTAL
Other: Vinegar Dressing

Normal Saline Dressing

ACTIVE COMPARATOR
Other: Normal Saline Dressing

Interventions

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.

Vinegar 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.

Normal Saline Dressing

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Central Study Contacts

Dr. MIAN MUHAMMAD BILAL Principal Investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 28, 2026

Study Start

February 4, 2026

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01