Custom-Molded Offloading Footwear Effectively Prevents Recurrence and Amputation, and Lowers Mortality Rates in High-Risk Diabetic Foot Patients: A Multicenter, Prospective Observational Study

Figures & data

Table 1 Baseline Characteristics of All Patients Participating in This Study

Variables	All Patients (n=48)	COT Group (n=31)	IOT Group (n=17)	P-value
Age, years	64.92±12.38	62.77±11.50	68.82±13.03	0.106
Height, cm	162.74±8.27	162.85±8.41	162.62±8.34	0.933
BMI, kg/m^2	24.46±2.99	24.35±2.45	24.60±3.61	0.804
Diabetes duration, years	11.33±7.56	11.91±7.57	10.59±7.71	0.595
Gender, %				0.212
Female	17(35.42)	9(29.03)	8(47.06)
Male	31(64.58)	22(70.97)	9(52.94)
Wagner classification, %				0.862
0–3	36(75.00)	24(77.42)	12(70.59)
4–5	12(25.00)	7(22.58)	5(29.41)
Diabetic retinopathy, %				0.195
Yes	23(47.92)	17(54.84)	6(35.29)
No	25(52.08)	14(45.16)	11(64.71)
Foot deformity, %				0.831
Yes	16(33.33)	10(32.26)	6(35.29)
No	32(66.67)	21(67.74)	11(64.71)
VPT>25volt, %				0.815
Yes	18(37.50)	12(38.71)	6(35.29)
No	30(62.50)	19(61.29)	11(64.71)
History of DFU, %				0.741
Yes	34(70.83)	21(67.74)	13(76.47)
No	14(29.17)	10(32.26)	4(23.53)
History of amputation, %				0.135
Yes	16(33.33)	8(25.81)	8(47.06)
No	32(66.67)	23(74.19)	9(52.94)
Plantar callus, %				0.507
Yes	20(41.67)	14(45.16)	6(35.29)
No	28(58.33)	17(54.84)	11(64.71)
Diabetic neuropathy, %				1
Yes	42(87.50)	27(87.10)	15(88.24)
No	6(12.50)	4(12.90)	2(11.76)
PAD, %				0.263
Yes	23(47.92)	13(41.94)	10(58.82)
No	25(52.08)	18(58.06)	7(41.18)
Ischemia, %				0.202
Yes	31(64.58)	18(58.06)	13(76.47)
No	17(35.42)	13(41.94)	4(23.53)
Osteoporosis, %				0.263
Yes	25(52.08)	18(58.06)	7(41.18)
No	23(47.92)	13(41.94)	10(58.82)
Methods of blood glucose control, %				0.907
Insulin	2(4.16)	1(3.22)	1(5.88)
Anti-hyperglycemic drugs	20(41.67)	13(41.94)	7(41.18)
Anti-hyperglycemic drugs and Insulin	26(54.17)	17(54.84)	9(52.94)

Abbreviations: COT, continuous offloading therapy; IOT, interrupted offloading therapy; BMI, body Mass Index; VPT, vibrating perception threshold; DFU, diabetic foot ulcer; PAD, peripheral artery disease.

Figure 1 A flow chart describing the study design.

Figure 2 Profiles of patients’ foot conditions and offloading therapy. Patient A: Recurrent neuropathic plantar foot ulcer on the left heel and the fifth right plantar metatarsophalangeal joint (A1). Personalized offloading insoles (A2). Wearing of the offloading footwear (A3). Patient B: Recurrent neuropathic plantar foot ulcer on the right foot and amputation of the first and third toes of the left foot (B1). Personalized offloading and orthopedic insoles (B2). Wearing the offloading footwear (B3).

Figure 3 Clinical outcomes of patients included in the study. *There were statistically significant difference in recurrence, amputation and mortality rates between patients in the continuous offloading therapy and those e in the interruption offloading therapy groups (P<0.01).