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

Study Overview
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Brief Summary
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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)

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

Conditions
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Diabetic Wound

Intervention / Treatment
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* Device: vacuum device
* Other: conventional dressing therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br> | Device: vacuum device<br>* use of vacuum device in dressing of diabetic wounds<br>|
| Active Comparator: group B<br> | Other: conventional dressing therapy<br>* us of conventional dressing with betadine and iruxol in diabetic wounds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of healing | healing progress | 6 months |