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. 2021 Jan 19;10(2):371. doi: 10.3390/jcm10020371

Table 3.

Previous studies of treatments of diabetic foot osteomyelitis with gentamicin-loaded calcium sulphate-hydroxyapatite biocomposite.

Author (Year) Study Design Patients Intervention Follow-Up Results QUADAS-2 Score [37]
This
study 		Multicenter
RCS		 Inclusion of 64 patients with DFO after unsuccessful conventional treatment (antibiotic therapy alone, or surgical debridement or minor amputation with adjunctive antibiotic therapy).

  • Surgical debridement, dead space filling with gentamicin-loaded CaS-HA biocomposite, closure of skin and soft tissues. Procedures involved minor amputations in 8 patients (13%).

 Median 43 (IQR, 20–61) weeks.

  • Wound healing in 54 patients (84%) and treatment success in 42 (66%).

 Risk of bias:

  • Postoperative offloading by non-weight bearing mobilization in 33 patients (52%), nonremovable knee-high devices in 14 (22%), removable knee-high devices in 2 (3%), and removable ankle-high devices in 15 (23%) for median 6 (IQR, 5–8) weeks.

  • Treatment failures (no wound healing) in 10 patients (12%).

  • Patient selection: Low risk

  • Postoperative antibiotic therapy in 26 patients (41%) for a median 3 (IQR, 2–6) weeks.

  • Treatment failures (ulcer recurrence) in 12 patients (19%).

  • Index test: N/A

  • Minor amputations in 4 patients (6%) and major amputations in 7 (11%) because of treatment failures.

  • Reference standard: N/A

  • Weight-bearing mobilization at final follow-up in 50 patients (89%).

  • Flow and timing: Low risk
Applicability concerns:

  • Patient selection: Low risk

  • Index test: N/A

  • Reference standard: Low risk

Whisstock, et al. [29]
(2020)		 Single-
center
RCS		 Inclusion of 35 patients (aged 18–80 years) with DFO, with or without Charcot neuroarthropathy and an otherwise normal function of the lower extremity.

  • Surgical debridement, dead space filling with gentamicin-loaded CaS-HA biocomposite. Procedures involved partial calcanectomies in 3 patients, talectomy in 1, and external fixation in 6 (17%).

 12 months. Three patients lost to follow-up.

  • Bone infection cured in 26 patients (81%).

 Risk of bias:

  • Closure with dermal substitute (Hyalomatrix™) in 10 patients (29%).

  • Due to nonhealing, 1 minor and 3 major amputations were performed.

  • Patient selection: Low risk

  • Postoperative antibiotic therapy for 4–6 weeks

  • Weight-bearing mobilization was possible in 25 patients (96%) with cured bone infections

  • Index test: N/A

  • Postoperative offloading by total contact casts.

  • Reference standard: N/A

  • Flow and timing: Low risk

Applicability concerns:

  • Patient selection: Low risk

  • Index test: N/A

  • Reference standard: Low risk

Hutting,
et al. [28] (2019) 		Case report Treatment of 1 patient with CN-related deformity and midfoot DFO after unsuccessful surgical treatment.

  • Surgical debridement of DFO, dead space filling with gentamicin-loaded CaS-HA biocomposite, primary closure of skin and soft tissues.

 12 months

  • Wound healing after 4 months.

 Risk of bias:

  • No ulcer recurrence during follow-up.

  • Patient selection: Unclear

  • Enteral amoxicillin/clavulanate for 4 months.

  • Able to mobilize weight-bearing.

  • Index test: N/A

  • Reference standard: N/A

  • Flow and timing: Unclear

Applicability concerns:

  • Patient selection: Low risk

  • Index test: N/A

  • Reference standard: Low risk

Niazi,
et al. [23] (2019)		 Multicenter
RCS		 Inclusion of 70 patients with DFO of the forefoot (62%), midfoot (33%), or hindfoot (5%). CN-related deformity in 9 patients (13%)

  • Surgical debridement of DFO, dead space filling with gentamicin-loaded CaS-HA biocomposite (using the “Silo technique” in case of calcaneal DFO) [24], primary closure of skin and soft tissues or VAC. Procedures involved minor amputations in 2 patients (3%).

 Mean 10
(range, 4–28) months

  • Wound healing in 57 patients (81%) after a mean of 12 (range, 4–16) weeks.

 Risk of bias:

  • Antibiotic therapy for mean 4 (range, 2–6) weeks.

  • Eradication of infection in 63 patients (90%).

  • Patient selection: High risk

  • Treatment failures in 7 patients (10%).

  • Index test: N/A

  • Major amputations in 5 patients (7%) due to treatment failures.

  • Reference standard: N/A

  • No recurrence of infection.

  • Flow and timing: High risk
Applicability concerns:

  • Patient selection: Low risk

  • Index test: N/A

  • Reference standard: Low risk

Drampalos, et al. [24] (2018) Single-center
RCS		 Inclusion of 12 patients with calcaneal DFO without involvement of the posterior subtalar joint.

  • Surgical resection, filling of drilled tunnels in the calcaneus with gentamicin-loaded CaS-HA biocomposite (“Silo technique”), primary closure or VAC.

 Mean 16
(range, 12–18) weeks

  • Wound healing in 12 patients (100%) after mean 16 (range, 12–18) weeks.

 Risk of bias:

  • Antibiotic therapy for 6–12 weeks.

  • Postoperative ambulation in 6 patients.

  • Patient selection: High risk

  • Index test: N/A

  • Reference standard: N/A

  • Flow and timing: High risk

Applicability concerns:

  • Patient selection: Low risk

  • Index test: N/A

  • Reference standard: Low risk

RCS: Retrospective cohort study. IQR: Interquartile range. CN: Charcot neuroarthropathy. DFO: Diabetic foot osteomyelitis. CaS-HA: Calcium sulphate–hydroxyapatite. VAC: Vacuum assisted closure. N/A: Not applicable.