NCT04093635|Unknown
Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
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Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
Sponsor study identifier
observational
40
0 countries
N/A
Study Start
November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 16, 2019
Actual (reported)September 18, 2019
Actual (reported)November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Management of diabetic foot ulcers.
Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.
one year
Those patients that will be treated by NPWT.
Those patients will be treated with standard saline moist wound care and dressing.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
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.
Liu 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.
First Submitted
September 16, 2019
First Posted
September 18, 2019
Study Start
November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
James 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.
Borys 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.
Hu 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.
November 2020
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 18, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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