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

NCT06450015 | Completed

• 1 other identifier: adeel6
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• time to wound healing

  total time for wound healing was assessed.

  1 month

Study Arms (2)

Vacuum Assisted Closure therapy

EXPERIMENTAL

Diabetic wounds managed wit VAC dressing

Device: Vacuum Assisted Closure

Saline Dreesing

EXPERIMENTAL

Saline dressing was done in these patients

Other: Saline Dressing

Interventions

Vacuum Assisted Closure DEVICE

VAC applied after debridement and saline packing

Vacuum Assisted Closure therapy

Saline Dressing OTHER

Wound was managed by saline dressing

Saline Dreesing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children Hospital and Institute of Child Health, Lahore: lead

Study Sites (1)

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Adeel Ashiq, MS

  The Children Hospital

  PRINCIPAL INVESTIGATOR

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

Model Details: effectiveness of Vacuum Assisted Closure therapy with saline dressing in management of diabetic foot ulcers

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: January 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 30, 2022
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)