NCT04093635

Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Negative Pressure Wound Therapy	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

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-11-01
• Completion: 2021-01-01
• First posted: 2019-09-18
• Last updated: 2019-09-18