Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153953
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-11-22
Brief Title:
A Comparative Study Between Vacuum Therapy Dressing and Conventional Dressing in Management of Diabetic Wounds
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
A Comparative Study Between Vacuum Therapy Dressing and Conventional Dressing in Management of Diabetic Wounds
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetes is a global epidemic and a leading cause of death by disease An estimated 366 million people worldwide had diabetes in 20111The incidence of diabetic foot ulcers DFUs and diabetic complications increases as the age increases2Up 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 amputation34Diabetic 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 rate5The 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 development6Vacuum 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 pressure7In 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 pressure8The 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 wound89NPWT was first proposed by Argenta and Morykwas in 1997 From then it has been approved as an effective modality of dressing in chronic wounds1NPWT 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 ie maceration and eczema and sudden increase in body temperature10
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None