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

NCT ID: NCT06450015

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-07-30

Brief Summary

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.

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.

Conditions

Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vacuum Assisted Closure therapy

Diabetic wounds managed wit VAC dressing

Group Type: EXPERIMENTAL

Vacuum Assisted Closure

Intervention Type: DEVICE

VAC applied after debridement and saline packing

Saline Dreesing

Saline dressing was done in these patients

Group Type: EXPERIMENTAL

Saline Dressing

Intervention Type: OTHER

Wound was managed by saline dressing

Interventions

Vacuum Assisted Closure

VAC applied after debridement and saline packing

Intervention Type: DEVICE

Saline Dressing

Wound was managed by saline dressing

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children Hospital and Institute of Child Health, Lahore

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Adeel Ashiq

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adeel Ashiq, MS

Role: PRINCIPAL_INVESTIGATOR

The Children Hospital

Locations

The Children Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

adeel6

Identifier Type: -

Identifier Source: org_study_id