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Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT04093635
Recruitment Status : Unknown
Verified September 2019 by Abdelrahman Ibrahim Sayed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Ibrahim Sayed, Assiut University

Study Description
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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.


Condition or disease Intervention/treatment
Diabetic Foot Ulcer Device: Negative Pressure Wound Therapy

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group I
Those patients that will be treated by NPWT.
 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
Group II
Those patients will be treated with standard saline moist wound care and dressing.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Management of diabetic foot ulcers. [ Time Frame: one year ]
    Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093635


Contacts
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Contact: Abdelrahman Ibrahim 01009842539 abdoibrahim93@yahoo.com
Contact: Mustafa Saad 01020990128 moskavasc@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Abdelrahman Ibrahim Sayed, Vascular Surgery Department, Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT04093635    
Other Study ID Numbers: VAC in DFUs
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases