Meta AnalysisID 4017

蛋白酶调节敷料用于糖尿病足溃疡或下肢静脉溃疡的临床疗效、生活质量及经济结局:一项综述

CRD42017082744

1. Are protease modulating treatments a clinically effective treatment for Diabetic Foot Ulcers (DFU) or Venous/Arterial Leg Ulcers (LU)? 2. Does the use of a protease modulating intervention influence a patient’s quali

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Record Fields

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Meta Analysis Id
4017
Evidence Id
12575
Core Evidence Id
12575
Source Meta Analysis Id
3976
Herb2 Meta Analysis Id
HBMA003976
Crd Id
CRD42017082744
Title
A review of clinical efficacy, quality of life, and economic outcomes associated with use of  protease-modulating dressings with diabetic foot ulcer or venous leg ulcer
Review Question
1. Are protease modulating treatments a clinically effective treatment for Diabetic Foot Ulcers (DFU) or Venous/Arterial Leg Ulcers (LU)? 2. Does the use of a protease modulating intervention influence a patient’s quality of life? 3. What is the economic impact of using protease modulating treatments for DFU and LU?
Study Type Included
We will include randomised controlled trials, observational trials, database studies and economic modelling. All other study designs, review articles, expert opinion and guidance documents will be excluded.
Condition Being Studied
Chronic wounds include leg ulcers, foot ulcers, pressure ulcers, non-healing surgical, burns and trauma wounds. These wounds frequently present as a symptom of an underlying chronic comorbidity such as diabetes, or venous/arterial disease. They may last for many months or even years, causing a burden felt by patients, the healthcare system and the wider economy. Diabetic foot ulcers and ulcers that are caused by underlying venous or arterial disease are an example of long lasting wounds. These patients are also likely to have a recurrence after their wound closes, and the ideal treatment pathway is still uncertain. Many new interventions are available with varying qualities of evidence to support their claims. Wound dressings are a mainstay of treatment; being applied to a wound as part of the wider treatment strategy, which may include compression, debridement, offloading and infection control to achieve full wound closure. Dressings have been categorised by the British National Formulary (BNF) as basic, advanced, antimicrobial, and specialised. Protease-modulating-matrix (PMM) dressings are dressings that have an effect on the matrix-metalloproteases (MMPs) that are present in chronic wounds. PMM is also available in topical form. These interventions are intended to rebalance the levels of MMPs in the wound bed, stimulating healing and improving outcomes. There is uncertainty surrounding the clinical and cost-effectiveness of these interventions, and the benefits felt by patients to their quality of life (QoL). This uncertainty is reinforced by national NG19 and SIGN Guidelines which do not offer any specific guidance on dressings or PMM. 
Participant
This study will include studies of patients with chronic wounds confirmed to be diabetic, venous or arterial in origin. All other aetiologies of leg ulcers; foot ulcers; pressure ulcers, and non-healing surgical, burns and trauma wounds will be excluded. Methods to diagnose a venous, arterial or diabetic wound may vary and this review will accept any as described by the included the studies.
Animal
Human Disease Modelled
Intervention
We will include relevant studies and articles that evaluate protease-modulating matrix dressings and topical applications. We will include all versions of these interventions, including, for example, protease-modulating dressings impregnated with other agents, such as antimicrobials (e.g. silver).
Comparator Control
Any
Main Outcome
Full wound closure (healing), time to closure.  
Outcome Measure
Additional Outcome
Absolute or relative Wound Area Reduction (WAR), rate of WAR, adverse events including infection, amputation, gangrene or any other escalation of wound status according to clinical presentation. Any patient reported outcome measures (PROMs) reporting health-related quality of life and pain, or any non-validated patient or clinician satisfaction measure. Resource utilisation data, including frequency of dressing changes, healthcare provider cost, and any financial cost borne by the patient or carers.
Study Method
Cost effectiveness, Intervention, Systematic review
Keyword
Bandages; Diabetic Foot; Humans; Peptide Hydrolases; Quality of Life; Treatment Outcome; Varicose Ulcer
Contact
April Betts [email protected]
Organisational Affiliation
Manchester Metropolitan University mmu.ac.uk
Funding Source
Manchester Metropolitan University, Urgo Medical UK
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language
English
Country
England
Review Stage
Review Ongoing
First Submission Date
2017-12-16
Registration Date
2017-12-18
Anticipated Start Date
2017-12-11
Anticipated Completion Date
2018-07-31
Title Cn
蛋白酶调节敷料用于糖尿病足溃疡或下肢静脉溃疡的临床疗效、生活质量及经济结局:一项综述
Title En
A review of clinical efficacy, quality of life, and economic outcomes associated with use of  protease-modulating dressings with diabetic foot ulcer or venous leg ulcer
Bilingual Status
complete