This is not the most recent version of the article. View current version (13 JAN 2016)

Intervention Protocol

You have free access to this content

Intensive versus conventional glycaemic control for treating diabetic foot ulcers

  1. Malindu E Fernando1,2,*,
  2. Ridmee M Seneviratne1,
  3. Margaret Cunningham1,
  4. Peter A Lazzarini3,4,
  5. Kunwarjit S Sangla5,
  6. Yong Mong Tan5,
  7. Petra G Buttner6,
  8. Jonathan Golledge1,7

Editorial Group: Cochrane Wounds Group

Published Online: 11 OCT 2013

DOI: 10.1002/14651858.CD010764


How to Cite

Fernando ME, Seneviratne RM, Cunningham M, Lazzarini PA, Sangla KS, Tan YM, Buttner PG, Golledge J. Intensive versus conventional glycaemic control for treating diabetic foot ulcers (Protocol). Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD010764. DOI: 10.1002/14651858.CD010764.

Author Information

  1. 1

    School of Medicine and Dentistry, James Cook University, Vascular Biology Unit, Queensland Research Centre for Peripheral Vascular Disease, Townsville, Queensland, Australia

  2. 2

    Kirwan Community Health Campus, Department of Podiatry, Townsville, Queensland, Australia

  3. 3

    Queensland Health, Allied Health Research Collaborative, Herston, Brisbane, Queensland, Australia

  4. 4

    Queensland University of Technology, School of Clinical Sciences, Brisbane, Queensland, Australia

  5. 5

    The Townsville Hospital, Department of Diabetes and Endocrinology, Townsville, Queensland, Australia

  6. 6

    James Cook University, School of Public Health and Tropical Medicine, Townsville, Queensland, Australia

  7. 7

    The Townsville Hospital, Department of Vascular and Endovascular Surgery, Townsville, Queensland, Australia

*Malindu E Fernando, Department of Podiatry, Kirwan Community Health Campus, Townsville, Queensland, Australia. malindu.fernando@my.jcu.edu.au.

Publication History

  1. Publication Status: New
  2. Published Online: 11 OCT 2013

SEARCH

This is not the most recent version of the article. View current version (13 JAN 2016)

 
Table 1. Diabetic foot management guidelines and levels of evidence

Guideline and management recommendations Level of evidence

(According to Oxford Centre for Evidence-based Medicine - Levels of Evidence (March 2009))
Glycaemic target

National Health and Medical Research Council (NHMRC):  Prevention, identification and management of foot complications in diabetes mellitus 2011

  • Local sharp debridement
  • Topical hydrogel dressings
  • Pressure reduction
  • Offloading
  • Removable offloading
  • Multidisciplinary care management
  • Negative pressure therapy
  • Hyperbaric oxygen
  • Larval therapy
  • Cultured skin equivalents
  • Skin grafting


Note: as per NHMRC levels of evidence
 

Expert opinion

Grade B

Grade B

Grade B

Expert opinion

Grade C

Grade B

Grade B

Grade C

Grade B

Grade D

 
 

Not reported

National Clearinghouse Guidelines  2011

  • Debridement with multidisciplinary team
  • Off-loading of foot ulcers
  • Pressure relieving support surfaces
  • Negative pressure wound therapy
  • Avoid the use of:
    • dermal or skin substitutes
    • electrical stimulation therapy
    • autologous platelet-rich plasma gel
    • regenerative wound matrices and dalteparin
    • growth factors
    • hyperbaric oxygen therapy
Not reportedHbA1c < 7%

Level B

National Clearinghouse guidelines 2012

(treatment of neuropathic wounds)

Assessment by a wound expert
  

 

Grade C
 

National Health Service (NHS): Type 2 diabetes: prevention and management of foot problems 2004

  • Urgent attention within 24 hours
  • Multidisciplinary treatment
  • Multidisciplinary team comprising of a podiatrist, orthotists, specialised nurse, diabetologist; with unhindered access to suites for managing major wounds, antibiotic administration, urgent inpatient facilities, community nursing, microbiology and diabetic services
  • Prompt Revascularisation
  • Intensive systemic antibiotic therapy
  • Appropriate wound dressing
  • Close monitoring and regular wound dressing changes
  • Debridement of dead tissue
  • Total contact casting
  • Hyperbaric oxygen, cultured human dermis, topical ketanserin or growth factors
  • Foot care reminders
 

Grade D

Grade D

Grade D

Grade D

Grade C

Grade D

Grade D

Grade B

Grade B

Grade D

Grade B
 

Not reported

 

 

 

National Health Service (NHS): 2011 National Institute for Health and Care Excellence (NICE) clinical guideline. Developed by the Centre for Clinical Practice at NICE: Diabetic foot problems: inpatient management of diabetic foot problems

  • Debridement
  • Wound dressings
  • Offloading
  • Antibiotics for infection
  • Timing for surgical management.          
 

 

 

 

Not reported
 

 

 

 

Not reported

2012 International Working Group on Diabetic Foot (IWGDF): Global guideline for type 2 diabetes

  • Local wound care
  • Relief of pressure
  • Treatment of infection
  • Metabolic control
  • Restoration of skin perfusion
 

Not reported

 

 
 

< 8 mmol/l

 

 

 

 

Australian Diabetes Foot Network: Management of diabetes related foot ulceration - a clinical update

  • Debridement
  • Dressing selection
  • Pressure offloading
  • Management of infection
  • Glycaemic control
  • Multidisciplinary care
 

 

 

Not reported
 

 

 

 Not reported

American College of Foot and Ankle surgeons 2006 (revision): Diabetic foot disorders – a clinical practice guideline

  • Debridement
  • Pressure offloading
  • Treatment of infection
  • Optimise metabolic perturbations
 

 

Not reported
 

 

Not reported

Scottish Intercollegiate Guidelines Network (SIGN) Guidelines 2010

  • Referral to a multidisciplinary care team
  • Total contact casts for unilateral ulcers
  • Irremovable walkers
  • Negative pressure wound therapy
  • Arterial reconstruction for those who require it 
 

Grade C

Grade B

Grade B

Grade B

Grade B
Not reported

American Diabetes Association Standards of Medical Care in Diabetes 2012

Multidisciplinary approach

Foot ulcers and wound care may require care by a podiatrist, orthopedic or vascular surgeon, or rehabilitation specialist experienced in the management of individuals with diabetes
 

Grade B

Not reported
 

As per position Statement for optimal Control

 

 
Table 2. HbA1c targets recommended by different international guidelines ª

CountryGuidelineYearHba1c targets in adultsLevel of Evidence

(According to Oxford Centre for Evidence-based Medicine - Levels of Evidence (March 2009))

AustraliaNational Health and Medical Research Council/Diabetes Australia2009

 
≤ 7%Grade A

Australian Paediatric Endocrine Group/ Australian Diabetes Society2011≤ 7%Grade D

 UKNational Institute for Health and Care Excellence (NICE)

 

- Managing type 1 DM diabetes in adults

 

- Blood glucose lowering therapy for type 2 DM
 

2012

  

2012
 

 ≤ 7.5% if increased arterial risk

≤ 6.5%  Between 6.5% and 7.5%
Grade B

 

Not reported

  

Not reported

Scottish Intercollegiate Guidelines Network (SIGN)

 - Type 1  Diabetes

 - Type 2 Diabetes
2010 

No set figure

 < 7%
 

Not reported

Grade A

USA

 
National Clearinghouse

 
2012< 7% or individualize to a goal of < 8%Grade B

American Diabetes Association

 
2012≤ 7% or individualise to a goal:

< 6.5%

 < 8%
Grade B

Grade C

Grade B

American  Association of Clinical Endocrinologists2011≤ 6.5% Grade D

International Diabetes Federation (IDF)International Diabetes Federation- Global Guideline  for type 2 Diabetes2012< 7.0%U/K

CanadaCanadian Diabetes Association

 
2008≤ 7%

 ≤ 6.5% (may be considered to lower risk of nephropathy further)
Grade C, Level 3

Grade A, Level 1A

EuropeEuropean Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA)2012< 7% or individualise to a goal of:

6-6.5% (patients with short disease, duration, long life expectancy, no significant CVD)

7.5–8.0% (history of severe hypoglycaemia, limited life expectancy, advanced complications, extensive comorbid conditions and those in
whom the target is difficult to attain)
Not reported

New ZealandNew Zealand Group Guidelines2003≤ 7%Grade D

 ª Adapted from Australian Electronic Therapeutic Guidelines (Electronic Therapeutic Guidelines Australia 2012)
Abbreviations
CVD = cerebrovascular disease
DM = diabetes mellitus
U/K = unknown
 
Table 3. Commonly used medications in diabetes mellitus (type 1 and type 2) for the management of hyperglycaemia.

Class/DrugExpected decrease in HbA1c

ORAL ANTIDIABETIC THERAPY

Metformin1-2%

Sulfonylureas

  1. glibenclamide
  2. gliclazide
  3. glimepiride
  4. glipizide
1-2%

DPP-4-inhibitors

  1. sitagliptin
  2. vildagliptin,
  3. axagliptin
  4. linagliptin
0.5-0.8%

Acarbose0.5-0.8%

Thiazolidinedione (glitazones)

  1. pioglitazone
  2. rosglitazone
0.5-1.4%

PARENTERAL THERAPY

GLP-analogues

exenatide

liraglutide

lixisenatide
0.5-1.0%

Insulin1.5-3.5%

InsulinGeneric name

Very-short-acting (rapid)Aspart

Glulisine

Lispro

Short-actingNeutral

Intermediate-actingIsophane (protamine suspension)

Long-actingDetermir

Glargine

BiphasicNeutral/isophane

Lispro/lispro protamine

Aspart/aspart protamine

Methods of insulin delivery

  1. Syringe
  2. Pen injector
  3. Pump/continuous subcutaneous insulin infusion

 
Table 4. Alternative treatments for lowering blood glucose in people with diabetic foot ulcers

Nature of intervention

Exercise Psychological and behavioural Dietary

Any exercise intervention that has the primary aim of improving glycaemic control in people with diabetes, where the impact of the intervention on glycaemic control and changes in an active foot ulcer has been documentedAny psychological or behavioural intervention that has the primary aim of improving glycaemic control in people with diabetes, where the impact of the intervention on glycaemic control and the resultant changes in a foot ulcer has been documentedAny dietary or nutritional intervention that has the primary aim of improving glycaemic control in people with diabetes, where the changes in glycaemic control have been correlated with changes in active foot ulcer outcome

Examples

Exercise programs of any intensity and duration that had the primary aim of improvement in glycaemic controlFrequent checking of blood glucose levels, interventions aimed at good pharmaceutical practice (i.e. improving compliance with medication)Healthy eating programs, dietary or nutritional supplements