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A Comparative Study Between Vacuum Therapy Dressing and Conventional Dressing in Management of Diabetic Wounds

NCT06153953 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-12-01

No results posted yet for this study

Summary

Diabetes is a global epidemic and a leading cause of death by disease. An estimated 366 million people worldwide had diabetes in 2011.(1).The incidence of diabetic foot ulcers (DFUs) and diabetic complications increases as the age increases.(2).Up to 25% of patients with diabetes will suffer from a foot ulcer during their lifetime. Ulceration is a pivotal factor in the causal pathway to infection and amputation.(3,4).Diabetic foot ulcers (DFUs) are the main cause of hospitalization in diabetic patients and they are considered a worldwide health problem. In recent years, the improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate.(5).The etiology of DFU is complex and rarely unifactorial. In general, foot ulcers are the cumulative result of repetitive trauma that wears a hole in the skin. The triad of neuropathy, foot deformity, and minor considers as the major contributing factors of ulcer development.(6).Vacuum therapy or Negative Pressure Wound Therapy is a technology uses a piece of foam in contact with the wound bed, covered by an occlusive dressing and placed under sub atmospheric pressure.(7).In other words NPWT is a non-invasive therapy system that uses 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 collection container using sub-atmospheric pressure.(8).The system produces granular tissue that has a characteristic rough appearance. The device can decrease the depth and area of large diabetic foot wounds into a shallow, smaller wound.(8,9).NPWT was first proposed by Argenta and Morykwas in 1997. From then it has been approved as an effective modality of dressing in chronic wounds.(1).NPWT is a safe modality of dressing it has shown a few complications. Minor complications encountered in the vacuum-treated patients : erosion of adjacent tissue due to increased local pressure underneath the tubing ,mild reactions of the peri-wound area (i.e. maceration and eczema) , and sudden increase in body temperature.(10)

Conditions

  • Diabetic Wound

Interventions

DEVICE

vacuum device

use of vacuum device in dressing of diabetic wounds

OTHER

conventional dressing therapy

us of conventional dressing with betadine and iruxol in diabetic wounds

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-05-31
Completion
2024-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153953 on ClinicalTrials.gov