Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
1 other identifier
observational
40
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 18, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedSeptember 18, 2019
September 1, 2019
1 year
September 16, 2019
September 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Management of diabetic foot ulcers.
Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.
one year
Study Arms (2)
Group I
Those patients that will be treated by NPWT.
Group II
Those patients will be treated with standard saline moist wound care and dressing.
Interventions
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
Eligibility Criteria
The study population will include patients diagnosed as DFU from November 2019 to November 2020 at Assiut University Hospital. The patients will divide into two groups: Group I: Those patients that will be treated by NPWT. Group II: Those patients will be treated with standard saline moist wound care and dressing. Each group consists of 20 patients.
You may qualify if:
- Acute and chronic diabetic wounds, pressure ulcers.
- Wagener's Grade I superficial diabetic ulcer.
- Wagener's Grade II after surgical debridement and an appropriate antibiotic therapy.
- Ischemic wounds after revascularization.
You may not qualify if:
- \- Wagener's Grade III, osteomyelitis and Charcot's joint septic arthritis.
- Wagener's Grade IV, localized gangrene e.g. toe ,heel.
- Wagener's Grade V, extensive gangrene involving the whole foot.
- Septicemia. .
- Gas forming organism.
- Wounds resulting from venous insufficiency.
- Peripheral vascular disease (absent distal pulse).
- Patients being treated with corticosteroids, immunosuppressive drugs or chemotherapy
- Any other serious pre-existing cardiovascular, pulmonary and immunological disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Iheozor-Ejiofor Z, Newton K, Dumville JC, Costa ML, Norman G, Bruce J. Negative pressure wound therapy for open traumatic wounds. Cochrane Database Syst Rev. 2018 Jul 3;7(7):CD012522. doi: 10.1002/14651858.CD012522.pub2.
PMID: 29969521BACKGROUNDLiu S, He CZ, Cai YT, Xing QP, Guo YZ, Chen ZL, Su JL, Yang LP. Evaluation of negative-pressure wound therapy for patients with diabetic foot ulcers: systematic review and meta-analysis. Ther Clin Risk Manag. 2017 Apr 18;13:533-544. doi: 10.2147/TCRM.S131193. eCollection 2017.
PMID: 28458556BACKGROUNDJames SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18.
PMID: 31007506BACKGROUNDBorys S, Hohendorff J, Koblik T, Witek P, Ludwig-Slomczynska AH, Frankfurter C, Kiec-Wilk B, Malecki MT. Negative-pressure wound therapy for management of chronic neuropathic noninfected diabetic foot ulcerations - short-term efficacy and long-term outcomes. Endocrine. 2018 Dec;62(3):611-616. doi: 10.1007/s12020-018-1707-0. Epub 2018 Aug 11.
PMID: 30099674BACKGROUNDHu X, Lian W, Zhang X, Yang X, Jiang J, Li M. Efficacy of negative pressure wound therapy using vacuum-assisted closure combined with photon therapy for management of diabetic foot ulcers. Ther Clin Risk Manag. 2018 Oct 25;14:2113-2118. doi: 10.2147/TCRM.S164161. eCollection 2018.
PMID: 30498354BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vascular Surgery Department, Assiut University
Study Record Dates
First Submitted
September 16, 2019
First Posted
September 18, 2019
Study Start
November 1, 2019
Primary Completion
November 1, 2020
Study Completion
January 1, 2021
Last Updated
September 18, 2019
Record last verified: 2019-09