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

NCT06153953 | Unknown

• 1 other identifier: Soh-Med-23-11-01MS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• duration of healing

  healing progress

  6 months

Study Arms (2)

group A

ACTIVE COMPARATOR

Device: vacuum device

group B

ACTIVE COMPARATOR

Other: conventional dressing therapy

Interventions

vacuum device DEVICE

use of vacuum device in dressing of diabetic wounds

group A

conventional dressing therapy OTHER

us of conventional dressing with betadine and iruxol in diabetic wounds

group B

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with diabetic non ischemic wounds which match the criteria suitable for the procedure.

You may not qualify if:

• Patients with chronic limb ischemia non-palpable distal pulsation.
• Lack of good hemostasis in the wound.
• Patients with malignant ulcers.
• Hepatic patients and patients receiving radio or chemotherapy.
• Wounds over untreated osteomyelitis.
• Wounds with fistulae to organs or body cavities.
• Presence of necrotic tissue.
• Exposed arteries/nerves/anastomotic site/organ

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.

  PMID: 16291063 BACKGROUND

• Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care. 2008 Apr;31(4):631-6. doi: 10.2337/dc07-2196. Epub 2007 Dec 27.

  PMID: 18162494 BACKGROUND

• Apelqvist J, Armstrong DG, Lavery LA, Boulton AJ. Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. Am J Surg. 2008 Jun;195(6):782-8. doi: 10.1016/j.amjsurg.2007.06.023. Epub 2008 Mar 26.

  PMID: 18355797 BACKGROUND

• Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair Regen. 2012 May-Jun;20(3):332-41. doi: 10.1111/j.1524-475X.2012.00780.x.

  PMID: 22564228 BACKGROUND

Central Study Contacts

Mohsen A ahmed attaelkareem, resident

CONTACT

01063846084; mohsenatta@med.sohag.edu.eg

osama A abdoabdelraheem, professor

CONTACT

01005452782

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident- vascular surgery- sohag university hospital

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11