Comparison of Vacuum Assisted Closure and Saline Dressing in Patients With Diabetic Foot Ulcers

June 4, 2024 updated by: Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore
Conventionally diabetic foot is treated with moist wound dressing and antibiotics but recent studies show that VAC dressing gives better results as compared to conventional saline dressing in treating Diabetic Foot Ulcers. This may decrease amputations rate, work load on hospitals, hospital stay, repeated hospital admissions, unemployment and can improve patient's quality of life. Objective of the study was to compare the effectiveness of Vacuum Assisted Closure therapy with saline dressing in management of diabetic foot ulcers in terms of granulation tissue formation and wound healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

it was a randomized Controlled Trial done in department of Surgery, Mayo Hospital,vLahore, Pakistan from January 2022 to July 2022. Patients divided in two groups, in the VAC group (Group A), the wound bed was filled with a saline soaked gauze piece after it is thoroughly cleaned. VAC was applied by placing sterile pads in two layers with a 16Fr Ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. The tube was connected to a wall mounted suction device and the pressure was set at -125 mmHg. In the Saline group (Group B), normal saline dressing was given. This consists of placing a saline soaked gauze piece over the wound bed after cleaning the wound. Patients were assessed and followed for wound healing. The primary outcome parameter was time taken to complete wound healing. Secondary outcome parameters were granulation tissue formation using a visual score and complication of bleeding, pain, and infection. Only healthy granulation tissue which appears pink was considered for scoring assessment. Infection was assessed by wound culture sensitivity which was sent every week.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 42000
        • The Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Diabetic foot ulcer (DFU) patients between the ages of 18 and 60

    • Patients of both genders
    • Diabetic foot ulcer (DFU) patients whose ulcers are smaller than 15 cm in diameter.

Exclusion Criteria:

  • • Coagulopathy

    • Venous diseases
    • Foot Ulcers with underlying Osteomyelitis
    • Charcot's joint
    • Peripheral Vascular Diseases
    • Patients with Wegener's Grade IV
    • Involving both feet
    • Patients with HIV and Chronic Liver Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Vacuum Assisted Closure therapy
Diabetic wounds managed wit VAC dressing
Device: Vacuum Assisted Closure
VAC applied after debridement and saline packing
Experimental: Saline Dreesing
Saline dressing was done in these patients
Other: Saline Dressing
Wound was managed by saline dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to wound healing
Time Frame: 1 month
total time for wound healing was assessed.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children Hospital and Institute of Child Health, Lahore

Investigators

  • Principal Investigator: Adeel Ashiq, MS, The Children Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • adeel6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

Clinical Trials on Vacuum Assisted Closure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe