Table 1

Summary characteristics of the included randomized controlled trials

Study
(country)
(funding)
Study population
(number of participants)
(study period)
Inclusion criteriaApplication of intervention
(number randomized)
Mean age (SD) in years
Mean HbA1c (SD)
Application of comparator
(number randomized)
Mean age (SD) in years
Mean HbA1c (SD)
Follow-up
(outcome measure)
Caravaggi
(Italy)
(not reported)15
PWD with neuropathic plantar ulcers
(60 subjects)
(January to October 2005)
Peripheral neuropathy, as highlighted by insensitivity to 10 g monofilament and vibration perception threshold measured by biothesiometer at malleolus of at least 25 volts, and presented with a neuropathic ulcer on the whole part of the plantar surface of the foot, including ulcers correlated with Charcot neuroarthropathy deformitiesFiberglass offloading
cast. Before applying the fiberglass bandages, a tubular Stockinet was placed onto the lower limb, which was first covered with German cotton to protect the skin, especially bony protrusions. A walking stirrup was used for support when the ulcer was localized in the mid-foot region, whereas a rubber heel was used when lesions were located on the forefoot, the plantar surface of the toes, or the heel
(29 subjects)
Mean age: not reported
Mean HbA1c: not reported
An Aircast Pneumatic Walker (XP Diabetic Walker). Its key elements include a semirigid plastic shell surrounding the limb, a removable front panel allowing easy access to the injured site, four individual internal air cells inflated with manometer at 20–30 mm Hg to hold the limb, a specifically designed rocker sole for improved offloading, and a dual-density insole. A hole was made on the insole at the ulcer site in order to offload the ulcer
(29 subjects)
Mean age: not reported
Mean HbA1c: not reported
Participants were followed up weekly for 90 days
(mean healing time)
Faglia
(Italy)
(Podartis, Italy, manufacturers of the Stabil-D walkers)16
PWD with non-ischemic, non-infected neuropathic plantar ulcer
(48 subjects)
(February 2008 through March 2009)
Neuropathic plantar forefoot ulcer with an area graded IA according to the University of Texas Classification of Diabetic Wounds. Peripheral neuropathy diagnosed based on insensitivity to a 10 g Semmes-Weinstein monofilament in more than six of nine areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiomete SLS, Nottingham, UK) at the malleolus of 25 V.Two types of fiberglass bandages were used for construction of the pressure-relief apparatus (Softcast3M; 3M Healthcare, Saint Paul, Minnesota, USA) imbued with a polyurethane resin with characteristics of flexibility and resistance, and Scotchcast3M; 3M Healthcare imbued with a polyurethane resin with high resistance to loading. A bandage with German cotton and tubular stockinet and pieces of protective rubber foam (Microfoam 3M; 3M Healthcare) were also applied
(25 subjects)
Mean age (SD): 59 (8.5) years
Mean HbA1c (SD): 9.1 (2.1)
Note: Data on HbA1c not reported for two participants
The comparator was the Stabil-D device. The cover was made of Elastam (Lycra), cast is provided with removable, lateral stabilizer inserts, a rigid brace made of a thermoformable polymer material properly supports the Achilles tendon and contributes to stability during rolling steps; such a brace can be adapted to the foot deformity using a hot air gun and malleolar forceps. The cast is closed dorsally with Velcro wrap
(23 subjects)
Mean age (SD): 61.7 (10.4) years
Mean HbA1c (SD): 7.5 (1.1)
Note: Data on HbA1c not reported for one participant
Participants were followed up weekly for 90 days. Ulcers were considered healed if they showed complete re-epithelization of the ulcerated area
(mean healing time)
Gutekunst
(USA)
(National Institutes of Health)17
PWD and one or more incident plantar ulcers presenting at the hospital wound care center, and at a physical therapy clinic
(23 subjects)
(not reported)
Having diabetes mellitus, peripheral neuropathy (PN), and plantar ulceration. Presence of diabetes mellitus confirmed by physician diagnosis; PN defined as a loss of protective sensation and was confirmed on clinical examination by a physical therapist. Plantar ulcers classified as Grade 1 or Grade 2 using the Wagner-Meggitt classification systemIntervention was made using plaster and fiberglass wrapping. A layer of low-density foam padding was used to cover the surface of the toes, and a pedar insole was then placed between the sock and the inner layer of plaster
(11 subjects)
Mean age (SD): 55 (13) years
Mean HbA1c (SD): 8.5 (2.3)
The pedar insole was placed in the bottom of the DH Pressure Relief Walker (Össur, Foothill Ranch, California, USA) with the data cord secured inside the walker boot.
(12 subjects)
Mean age (SD): 53 (10) years
Mean HbA1c (SD): 8.9 (1.8)
Not reported explicitly
(mean healing time)
Piaggesi
(Italy)
(not funded)18
PWD with diabetic foot ulcers attending highly specialized diabetic foot outpatient clinics
(40 subjects)
(not reported)
Type 1 or type 2 diabetes lasting for at least 5 years; presence of a forefoot plantar ulcer wider than 1 cm2, staged IA or IIA according to the University of Texas Diabetic Wound Classification, lasting at least 6 weeks; ankle-brachial pressure index ≥0.9 with two palpable pulses in the affected footIntervention was made using fiberglass material (Scotchcast longuettes and Softcast rolls; 3M Healthcare, Saint Paul, Minnesota, USA) with padding put over the ulcer, according to a previously well-described procedure
(20 subjects)
Mean age (SD): 61.4 (9.7) years
Mean HbA1c (SD): 8.1 (0.9)
The comparator was boots applied and customized according to manufacturer’s instructions, with accommodative offloading obtained by cutting a hole in the intermediate layer of the three-layered insole of the device corresponding to the lesion, in order to reduce the pressure in the area
(20 subjects)
Mean age (SD): 62.3 (9.2) years
Mean HbA1c (SD): 8.4 (1.0)
Participants were followed up weekly for 90 days or until complete healing of the lesion, which was defined as complete re-epithelialization.
(mean healing time)
Piaggesi
(Italy)
(Salvatelli srl, Civitanova
Marche, Italy, manufacturers of the Optima
Diab Molliter walkers used in the study)19
PWD attending the diabetic foot clinic of the University of Pisa, Italy
(40 subjects)
(April to October
2005)
Type 1 or type 2 diabetes lasting for at least 5 years; presence of peripheral neuropathy as highlighted by insensitivity to a 10 g monofilament and by a vibration perception threshold measured at malleolus of at least 25 volts, and have a forefoot plantar ulcer for a period of at least 3 weeks with an area wider than 1 cm2 graded 1A or 2A according to Texas University classificationIntervention was a non-removable fiberglass cast according to a technique positioning a layer of isolating foam in relation to the ulceration site. The fiberglass material used for manufacturing each cast was produced by 3M (Saint Paul, Minnesota, USA) and consisted of two Scotchcast longuettes to create the plantar support and block the ankle, and three Sofcast rolls to make the boot, and each cast was provided with one or two rubber heels to allow the subject to stand and walk
(20 subjects)
Mean age (SD): 59.8 (8.2) years
Mean HbA1c (SD): 7.9 (1.1)
The comparator was the Optima Diab device adapted according to the participant’s foot condition and secured to the participant’s leg with a plastic non-removable lace, which was an integral part of the device. The participant’s foot and leg were protected by a layer of cotton-wool to avoid friction with the device, and the three-layer insoles were modeled to accommodate the position of the ulcer site
(20 subjects)
Mean age (SD): 61.1 (6.4) years
Mean HbA1c (SD): 7.6 (0.9)
Participants were followed up weekly for 12 weeks or up to complete re-epithelialization of the lesions
(mean healing time)
  • HbA1c, Hemoglobin A1c; PWD, persons with diabetes; SD, standard deviation.