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

NCT ID: NCT06153953

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

group A

Group Type: ACTIVE_COMPARATOR

vacuum device

Intervention Type: DEVICE

use of vacuum device in dressing of diabetic wounds

group B

Group Type: ACTIVE_COMPARATOR

conventional dressing therapy

Intervention Type: OTHER

us of conventional dressing with betadine and iruxol in diabetic wounds

Interventions

vacuum device

use of vacuum device in dressing of diabetic wounds

Intervention Type: DEVICE

conventional dressing therapy

us of conventional dressing with betadine and iruxol in diabetic wounds

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• • 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohsen Ahmed Atta

resident- vascular surgery- sohag university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohsen A ahmed attaelkareem, resident

Role: CONTACT

Phone: 01063846084

Email: mohsenatta@med.sohag.edu.eg

osama A abdoabdelraheem, professor

Role: CONTACT

Phone: 01005452782

References

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.

Reference Type: BACKGROUND

PMID: 16291063 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18162494 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18355797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22564228 (View on PubMed)

Other Identifiers

Soh-Med-23-11-01MS

Identifier Type: -

Identifier Source: org_study_id