Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Those patients that will be treated by NPWT. | Device: Negative Pressure Wound Therapy<br>* 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 will be set at -125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs<br>|
| Group II<br>Those patients will be treated with standard saline moist wound care and dressing. | Device: Negative Pressure Wound Therapy<br>* 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 will be set at -125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of diabetic foot ulcers. | Assessment role of negative pressure wound therapy in treating diabetic foot ulcers. | one year |