Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Negative Pressure Wound Therapy

• Registration Number: NCT04093635
• Lead Sponsor: Assiut University

Brief Summary

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

• The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.

Detailed Description

Diabetic Foot ulcers are a major cause of admission in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in Hospital.

The improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate. The approach to diabetic foot ulcers has allowed the availability of several medical options to ensure the best local condition and wound healing.

Negative-pressure wound therapy is a non-invasive therapy system that employs a controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a container.

An earlier study has shown that NPWT reduced the need for subsequent amputations in a 6-month follow-up period. This reflects the importance of this device in management of DFUs and prevents its complications.

As most of the diabetic wounds present with infection, the success of NPWT is still highly dependent upon the adequacy of surgical debridement and antimicrobial coverage.

NPWT provides a moist wound environment ideal for re-epithelialization, growth factor action, angiogenesis, and granulation promotion.

Edema reduction produced by NPWT decreases interstitial pressure and positively promoting wound vessel formation and improving wound circulation and lymphatic drainage, increasing the availability of nutrients, oxygen and antibiotic therapy in the wound area. Some studies showed that NPWT promotes an improvement of balance between proteases and their inhibitors and influences cytokine modulation and promotes a positive wound environment.

Accurate classification of diabetic foot ulcers according to Wagner's classification of ulcers is essential for inter-clinician communication, assessment of healing tendency during management by NPWT.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Last Update Submitted: 2019-09-16
• Study First Posted: 2019-09-18
• Last Update Posted: 2019-09-18
• Study Start: 2019-11
• Primary Completion: 2020-11
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Acute and chronic diabetic wounds, pressure ulcers.
• Wagener's Grade I superficial diabetic ulcer.
• Wagener's Grade II after surgical debridement and an appropriate antibiotic therapy.
• Ischemic wounds after revascularization.

Exclusion Criteria

• • Wagener's Grade III, osteomyelitis and Charcot's joint septic arthritis.
• Wagener's Grade IV, localized gangrene e.g. toe ,heel.
• Wagener's Grade V, extensive gangrene involving the whole foot.
• Septicemia. .
• Gas forming organism.
• Wounds resulting from venous insufficiency.
• Peripheral vascular disease (absent distal pulse).
• Patients being treated with corticosteroids, immunosuppressive drugs or chemotherapy
• Any other serious pre-existing cardiovascular, pulmonary and immunological disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group II	Negative Pressure Wound Therapy	Those patients will be treated with standard saline moist wound care and dressing.
Group I	Negative Pressure Wound Therapy	Those patients that will be treated by NPWT.

Primary Outcome Measures

Name	Time	Method
Management of diabetic foot ulcers.	one year	Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.