Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

• ClinicalTrials.gov Identifier: NCT04093635
• Recruitment Status: Unknown
• First Posted: September 18, 2019
• Last Update Posted: September 18, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Abdelrahman Ibrahim Sayed, Assiut University

Tracking Information

• First Submitted Date: September 16, 2019
• First Posted Date: September 18, 2019
• Last Update Posted Date: September 18, 2019
• Estimated Study Start Date: November 2019
• Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2019)

Management of diabetic foot ulcers. [ Time Frame: one year ]

Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
• Official Title: Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

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.

Detailed Description

Diabetic Foot ulcers are a major cause of admission in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in Hospital.

The improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate. The approach to diabetic foot ulcers has allowed the availability of several medical options to ensure the best local condition and wound healing.

Negative-pressure wound therapy is a non-invasive therapy system that employs a 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 container.

An earlier study has shown that NPWT reduced the need for subsequent amputations in a 6-month follow-up period. This reflects the importance of this device in management of DFUs and prevents its complications.

As most of the diabetic wounds present with infection, the success of NPWT is still highly dependent upon the adequacy of surgical debridement and antimicrobial coverage.

NPWT provides a moist wound environment ideal for re-epithelialization, growth factor action, angiogenesis, and granulation promotion.

Edema reduction produced by NPWT decreases interstitial pressure and positively promoting wound vessel formation and improving wound circulation and lymphatic drainage, increasing the availability of nutrients, oxygen and antibiotic therapy in the wound area. Some studies showed that NPWT promotes an improvement of balance between proteases and their inhibitors and influences cytokine modulation and promotes a positive wound environment.

Accurate classification of diabetic foot ulcers according to Wagner's classification of ulcers is essential for inter-clinician communication, assessment of healing tendency during management by NPWT.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample

Study Population

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.

• Condition: Diabetic Foot Ulcer

Intervention

Device: Negative Pressure Wound Therapy

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

Study Groups/Cohorts

• Group I
  Those patients that will be treated by NPWT.
  Intervention: Device: Negative Pressure Wound Therapy
• Group II
  Those patients will be treated with standard saline moist wound care and dressing.
  Intervention: Device: Negative Pressure Wound Therapy

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 16, 2019): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2021
• Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04093635
• Other Study ID Numbers: VAC in DFUs
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Abdelrahman Ibrahim Sayed, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: September 2019