Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review.
BACKGROUND
Footwear and offloading techniques are commonly used in clinical practice for preventing and healing of foot ulcers in persons with diabetes. The goal of this systematic review is to assess the medical scientific literature on this topic to better inform clinical practice about effective treatment.


METHODS
We searched the medical scientific literature indexed in PubMed, EMBASE, CINAHL, and the Cochrane database for original research studies published since 1 May 2006 related to four groups of interventions: (1) casting; (2) footwear; (3) surgical offloading; and (4) other offloading interventions. Primary outcomes were ulcer prevention, ulcer healing, and pressure reduction. We reviewed both controlled and non-controlled studies. Controlled studies were assessed for methodological quality, and extracted key data was presented in evidence and risk of bias tables. Uncontrolled studies were assessed and summarized on a narrative basis. Outcomes are presented and discussed in conjunction with data from our previous systematic review covering the literature from before 1 May 2006.


RESULTS
We included two systematic reviews and meta-analyses, 32 randomized controlled trials, 15 other controlled studies, and another 127 non-controlled studies. Several randomized controlled trials with low risk of bias show the efficacy of therapeutic footwear that demonstrates to relief plantar pressure and is worn by the patient, in the prevention of plantar foot ulcer recurrence. Two meta-analyses show non-removable offloading to be more effective than removable offloading for healing plantar neuropathic forefoot ulcers. Due to the limited number of controlled studies, clear evidence on the efficacy of surgical offloading and felted foam is not yet available. Interestingly, surgical offloading seems more effective in preventing than in healing ulcers. A number of controlled and uncontrolled studies show that plantar pressure can be reduced by several conservative and surgical approaches.


CONCLUSIONS
Sufficient evidence of good quality supports the use of non-removable offloading to heal plantar neuropathic forefoot ulcers and therapeutic footwear with demonstrated pressure relief that is worn by the patient to prevent plantar foot ulcer recurrence. The evidence base to support the use of other offloading interventions is still limited and of variable quality. The evidence for the use of interventions to prevent a first foot ulcer or heal ischemic, infected, non-plantar, or proximal foot ulcers is practically non-existent. High-quality controlled studies are needed in these areas.
Department of Rehabilitation Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
S A
SA
Bus
School of Health Care Sciences, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.
R W
RW
van Deursen
Southern Arizona Limb Salvage Alliance (SALSA), University of Arizona College of Medicine, Tucson, Arizona, USA.
D G
DG
Armstrong
Cardiff and Vale University Health Board and Cardiff School of Health Science, Cardiff Metropolitan University, Cardiff, UK.
J E A
JE
Lewis
University Vita Salute San Raffaele and Diabetic Foot Clinic, Istituto Clinico Città, Studi, Milan, Italy.
C F
CF
Caravaggi
Department of Orthopaedics and Sports Medicine, University of Washington Medical Centre, Seattle, WA, USA.
P R
PR
Cavanagh
D003131:Combined Modality Therapy / Q000639:trends; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000628:therapy*; D017719:Diabetic Foot / Q000517:prevention & control* / Q000534:rehabilitation / Q000628:therapy; D019317:Evidence-Based Medicine; D005528:Foot / Q000098:blood supply / Q000601:surgery; D006801:Humans; D023821:Limb Salvage / Q000009:adverse effects / Q000639:trends; D009984:Orthopedic Fixation Devices / Q000639:trends; D010349:Patient Compliance; D010353:Patient Education as Topic; D057285:Precision Medicine; D011312:Pressure; D011482:Protective Devices / Q000639:trends; D012775:Shoes / Q000009:adverse effects; D035703:Therapies, Investigational / Q000009:adverse effects / Q000639:trends; D016474:Weight-Bearing
diabetes mellitus; diabetic foot; foot ulcer; footwear; healing; offloading; plantar pressure; prevention; shoes; surgery; systematic review