Table 1.
Therapeutic protocols used in the intervention and control groups in included studies focusing on the use of HBOT in DFU [5, 8, 32].
| First author and year of publication | Study group (no. of patients) |
Control group (no. of patients) |
|---|---|---|
| Löndahl et al., 2010 [33] | N = 49 | N = 45 |
| Evaluation of wether adjunctive treatment with HBOT compared with treatment with hyperbaric air (placebo) would have any therapeutic effect HBOT a treatment period at 2.5 ATA for 85 min daily (session duration 95 min), five days a week for 8 weeks (40 sessions) |
||
| Complete healing of the index ulcer was achieved in 25/48 (52%), 3 major amputations, 4 minor amputations | Complete healing of the index ulcer was achieved in 12/42 (29%), 1 major amputation, 4 minor amputations | |
|
| ||
| Duzgan, 2008 [34] | N = 50 | N = 50 |
| Standard therapy (ST) + HBOT HBOT 2-3 ATA for 90 min/2 sessions per day, followed by 1 session on the following day; 33% were healed without surgery treatment; 16% (8) required operative debridement, an amputation, or the use of a flap or skin graft; 8% (4) underwent distal amputation; 0 required proximal amputation |
ST daily wound care, dressing changes, local debridement, and control infection 0% of patients were healed without surgery treatment; 100% (50) required either operative debridement, an amputation, or the use of a flap or skin graft; 48% (24) underwent distal amputation; 34% (17) required proximal amputation |
|
|
| ||
| Abidia et al., 2003 [35] | N = 9 (100% oxygen) | N = 9(control—air) |
| HBOT 2.4 atmospheres absolute (ATA) for 90 min daily, 5 days per week, totaling 30 sessions | 2.4 atmospheres absolute (ATA) for 90 min daily, 5 days per week, totaling 30 sessions |
|
| Complete epithelialization was achieved in 5 out of 8 ulcers; the median decrease of the wound areas was 100% | Complete epithelialization was achieved in 1 of the 8 ulcers; the median decrease of the wound areas was 52% | |
|
| ||
| Kalani et al., 2002 [36] | N = 17 | N = 21 |
| 40–60 session of HBOT | Conventional treatment | |
| Investigation the long-term effect of HBOT, 76% of (13) patients had healed; 12% (2) were amputated | 48% of (10) patients had healed, 33% (7) were amputated | |
|
| ||
| Faglia et al., 1998 [19] | N = 51 | N = 64 |
| Comparison therapy plus treatment in a multiplace HBO chamber Two phases: (1) first (antibacterial) phase uses 100% oxygen at 2.5 ATA for 90 minutes daily; (2) second (reparative) phase uses 100% oxygen at 2.2–2.4 ATA for 90 minutes, 5 days a week |
Debridement, topical antimicrobial agents, and occlusive dressing. Empirical antibiotic therapy modified following sensitivity results. Diabetic control with insulin. PTCA or CABG, if needed | |
|
| ||
| Zamboni et al., 1997 [18] | N = 5 | N = 5 |
| Comparison therapy plus treatment in a monoplace HBO chamber with 100% oxygen at 2 ATA for 120 minutes, 30 sessions 5 days a week | Debridement, silver sulfadiazine dressing twice a day for 5 days, and culture-specific antibiotics | |
|
| ||
| Faglia et al., 1996 [20] | N = 35 | N = 33 |
| Comparison therapy plus treatment in a multiplace HBO chamber. Two phases: (1) first (antibacterial) phase uses 100% oxygen at 2.5 ATA for 90 minutes daily; (2) second (reparative) phase uses 100% oxygen at 2.2–2.4 ATA for 90 minutes, 5 days a week. Mean (SD) number of sessions = 38 (8) | Debridement, topical antimicrobial agents, occlusive dressing. Empirical antibiotic therapy modified following sensitivity results. Diabetic control with insulin. PTCA or CABG, if needed | |
|
| ||
| Doctor et al., 1992 [37] | N = 15 | N = 15 |
| Conventional management and 4 sessions of hyperbaric oxygen therapy HBO chamber with 100% oxygen at 3 ATA for 45 minutes, 4 sittings over 2 weeks |
Regular surgical treatment, incision and drainage, debridement, local dressing with boric acid and bleaching powdered solution, or glycerine acriflavine Amputation for gangrene or infection above the knee Cephalosporins, aminoglycosides, and metronidazole with changes made following sensitivity patterns Diabetic control with insulin | |
|
| ||
| Baroni et al., 1987 [17] | N = 18 | N = 10 |
| Comparison therapy plus treatment in a multiplace HBO chamber. Two phases: (1) first (antibacterial) phase uses 100% oxygen at 2.8 ATA for 90 minutes daily; (2) second (reparative) phase uses 100% oxygen at 2.5 ATA for 90 minutes. Mean (SD) number of sessions = 34 (21.8) | Debridement. Diabetic control with insulin | |