TABLE 4.
Characteristics of included studies
| First author and year | Country | Wound type | Wound site | Enrolment date | End date | Random sequence | Measurement tool | Funding | |
|---|---|---|---|---|---|---|---|---|---|
| Francesco Inchingolo, 2015 | Italy | Second‐ or third‐degree actinic ulcers following a radiotherapy cycle | NR | NR | NR | NR | NR | NR | |
| Laura Gheuca˘ Solova˘stru, 2015 | Romania | Chronic venous Leg ulcers | Leg | NR | NR | Randomly divided | A centimetre ruler | NR | |
| Yi‐Ting Zhou, 2016 | China | Lower limb venous ulcers | Lower limb | 2006.04 | 2012.07 | Computer‐generated random numbers and numbered envelopes | computerised planimetry | NR | |
| Hassanien M, 2018 | Egypt | Digital ulcers (DUs) in systemic sclerosis (SSc) | Digital | NR | NR | Assigned by computer‐based selection as ratio of 1:1 | Modified Rodnan skin score (MRSS) | NR | |
| Raffaele Marfella, 2009 | Italy | Critical limb ischemia (CLI) | Foot | NR | NR | Computer‐generated code lists | EZ graph | NR | |
| Enas Mohamed Ali, 2013 | Egypt | DFU | Foot | 2012.01 | 2012.04 | Randomised | Polythene sheet placed with a marker | NR | |
| Qin Xinyuan, 2020 | China | DFU | Foot | 2018.09 | 2019.09 | Random number table | Medical area measuring camera | The Capital Clinical Characteristic Application Research and Achievement Promotion. NO. Z171100001017070 | |
| Xiaoxiao Hu, 2019 | China | DFU | Foot | 2016.04 | 2017.08 | Randomised | A digital camera and analysed by ImageJ software | The project of Lnc‐MALAT1 which regulates the homing and biological function mechanism of endothelial progenitor cells in diabetic vascular disease (No.81671793) and the Fundamental Research Funds for the Central Universities (No.22120170092. | |
| Jing Zhang, 2014 | China | DFU | Foot | 2012.03 | 2013.01 | Randomised | film transparency tracings using grid paper | the 2010 special technological development of Guangdong industries, no. 2060403. | |
| Julio Wainstein, 2011 | Israel | DFU | Foot | NR | NR | Randomised | A transparent grid onto the wound | NR | |
| Morteza Izadi, 2019 | Iran | DFU | Foot | NR | NR | Randomised | A ruler | NR | |
| Gregorio Martínez‐Sánchez,2005 | Cuba | DFU | Lower extremities | NR | NR | Randomised | A computer program (DIGIPAT). | NR | |
| Duration of diabetes (treatment group/control group) | Duration of wound (treated group/control group) | Ages (treated group/control group) years | Intervention of treatment | Intervention of control | Man of treatment group N (%) | Woman of treatment group N (%) | Man of control group N (%) | Woman of control group N (%) | Number of patients(treatment/control) |
| / | 5/7 (days) | 62–65/62–65 | A mixture called ozolipoile. | Hyaluronic acid gel | NR | NR | NR | NR | NR (both groups are 13 participants) |
| / | 13/16(months) | 58/59 | Ozonated oil +α‐Bisabolol spray | Standard epithelialisation cream | 9 (60%) | 6 (40%) | 10 (71%) | 4 (29%) | 15/14 |
| / | At least 2 mo | 61.1 ± 11.2/60.2 ± 9.7 | Endovenous laser therapy (EVLT) + local ozone gas bath | Endovenous laser therapy (EVLT) + sham | 29(58%) | 21(42%) | 20(47%) | 22(53%) | 50/42 |
| / | NR | 38.83 ± 12.32/ 44.08 ± 10.42 | Calcium channel blockers+oxygen‐ozone gas bath | Calcium channel blockers | 0 | 25(100%) | 0 | 25(100%) | 25/25 |
| / | NR | 70 ± 5/69 ± 7 | Ozone‐based autologous blood immunomodulation therapy (IMT) | Sham therapy | 54(70%) | 23(30%) | 51(70%) | 23(31%) | 77/74 |
| mean duration 11.3 y (range 2–20 y.) | NR | 48–69(all participants) | Rectal insufflation+ ozone gas bath+ ozonised olive oil | Antifungal group: fluconazole; control group: standard care only | NR | NR | NR | NR | 20/20/20 |
| 23.8 y (range 9–40 y.)/22.9 y (range 11–39 y) | 0.95 y (1 mo–3 y)；0.98 y (1 mo–2 y) | 67.1(39–78)/65.5(40–75) | Cleaning the wound with local normal saline+ozone gas bath | Cleaning the wound with local normal saline+sham therapy | 27(54%) | 23(46%) | 25(50%) | 25(50%) | 50/50 |
| 13.3 ± 6.9 y/13.5 ± 6.1 y | 91.5 ± 25.3 d/94.5 ± 21.5 d | 53.5 ± 8.6/56.4 ± 10.4 | Ozone water flush +VAC | 0.9% saline flush +VAC | 37(54%) | 31(45%) | 35(51%) | 33(48%) | 68/68 |
| 8.64 ± 5.35 y/10.24 ± 5.47 y | 45.04 ± 8.6 d/46.6 ± 10.79 d | 61.12 ± 10.90/59.72 ± 12.20 | Standard treatment + ozone gas bath | standard treatment | 12(48%) | 13(52%) | 14(56%) | 11(44%) | 25/25 |
| 15.2 ± 9.7 y (1‐41 y)/16.4 ± 11.0 y (2‐45 y) | At least 8 wk | 62.6 ± 10.2 /62.6 ± 9.5 | Ozone gas bath + usual diabetic foot ulcer care | Sham treatments + usual diabetic foot ulcer care | 19 (59%) | 13(41%) | 19 (66%) | 10(34%) | 32/29 |
| NR | NR | 59.03 ± 12.593/53.5 ± 10.212 | Appropriate medical and surgical treatments + local ozone gas bath+ozonised olive oil +ozonated gel (ozolive) + injection of ozone‐oxygen + systemic ozone through rectal or intravenous administration | Appropriate medical and surgical treatments | 50(50%) | 50(50%) | 50(50%) | 50(50%) | 100/100 |
| 17 ± 11/18 ± 8 y | NR | 20–40(5);40–60(17); ≥60(30)/20–40(7);40–60(20); ≥60(22) | Rectal insufflation+ ozone bag+ozonised sunflower oil | Topical and systemic antibiotics | 26(50%) | 26(50%) | 30(61%) | 19(38%) | 51/49 |
| Number of ulcers(treatment/control) | Time of treatment | Followed up time | Baseline wound area of treatment/control (X ± SD) | Participants with complete healing of treated /control group and ratio | Participants with complete not‐healing and ratio of treated/control group | Ulcer number with complete healing of treated/control group | Ulcer number and ratio with complete not‐healing of treated /control group | Treatment efficient ratio of treated /control group | Wound area after treatment in the treated/control group (X ± SDcm 2 ) |
| NR | NR (until complete healing) | NR | 3.8 ± −/4.1 ± −cm2 (standard deviations NR) | NR | NR | NR | NR | NR | NR |
| 20/17 | 30 d | NR | 4.36 ± 5.61/4.59 ± 3.46 cm2 | 5(25%)/none (0) | NR | 5/none | NR | NR | 1.85 cm2 ± −/ NR |
| 50/42 | NR (until the ulcer area was improved and suitable for skin puncture.) | 12 mo | 5.3 ± 1.25/5.2 ± 1.34 cm2 | 46(92%) /32(76.19%) | 4(8%)/10(23.81%) | 46/32 | 4/10 | 92%/76.19% | NR |
| 25/25 | 20 d | NR | 3.61 ± 0.8/4.18 ± 0.38 mm | 7(28%)/3(12%) | 1(4%)/14(56%) | 7/3 | 1(4%)/14(56%) | 96%/44% | 0.75 ± 0.3/2.44 ± 0.80 mm |
| 53/49 | At least 22 wk or until study completion. | NR | 4.6 ± 2.4/4.4 ± 2.1 cm2 | 32(41%)/NR | NR | NR | NR | NR | NR |
| 20/20/20 | 20 d | 14 wk | 140 ± 2.8/142 ± 3(antifungal group)/133.5 ± 2.5(control group) cm2 | NR | NR | NR | NR | NR | 9.5 ± 0.1/88.5 ± 1.5(antifungal group)/98.7 ± 1.0 cm2(control group) |
| 50/50 | 3 wk | NR | 25.85 ± 8.77/23.29 ± 7.91 cm2 | NR | NR | NR | NR | NR | 4.65 ± 1.93/21.47 ± 8.14 cm2 |
| 68/68 | NR (until ulcer closure.) | 1 y | 37.5 ± 21.6/39.3 ± 22.8 cm2 | NR | NR | NR | NR | NR | NR |
| 25/25 | 20 d | NR | 11.74 ± 0.72/10.82 ± 0.93 cm2 | 6(24%)/3(12%) | 2(8%)/9(36%) | 6/3 | 2(8%)/9(36%) | 23(92%)/16(64%) | NR |
| 32/29 | 12 wk | 12 wk | 4.9 ± 4.4/3.5 ± 3.8 cm2 | 13(41%)/10(33%) | NR | 13/10 | NR | NR | NR |
| 100/100 | Until wound closure and epithelialisation (about 180 d) | NR | 13.41 ± 14.092/12.72 ± 0.911 cm2 | NR/75(75%) | NR/25(25%) | NR/75 | NR/25(25%) | NR | NR |
| 51/49 | 20 d | NR | 57.97 ± 0.52/54.84 ± 0.39 cm2 | 39(78%)/34(69%) | 12(24%)/15(30%) | 39/34 | 12(24%)/15(30%) | 39(78%)/34(69%) | 23.31 ± 0.36/40.72 ± 0.35 cm2 |
| Total wound closure area of the two groups (treatment/control) | Percentage reduction of wound area in treatment /control group | Time to achieve complete ulcer healing (treated/control group) (day) | Adverse events | Recurrence participants and ratio of treatment/control group | Amputation participants and ratio of treatment /control group | Length of hospital stay of treatment/control group | Life quality | Cost expenditure | Suspending the research |
| NR | NR | NR | No side effect | NR | NR | NR | NR | NR | NR |
| NR | 73%/13% | NR | No side effects | NR | NR | NR | NR | NR | NR |
| NR | NR | NR | pain, laser‐induced burn, paresthesia | 3(6.52%)/ 8(25.00%) | NR | NR | NR | NR | NR |
| NR | NR | NR | No side effect | NR | NR | NR | NR | NR | NR |
| NR | NR | NR | 53.2%/52.7% (treatment /control) | NR | NR | NR | NR | NR | NR |
| NR | 93.27%/37.6% (antifungal group)/26.06% (control group) | NR | 3 (control group) and 7 (antifungal group) patients anincrease in wound surface area | NR | NR | NR | NR | NR | NR |
| NR | 93.22 ± 1.86%/3.28 ± 0.55% | NR | No side effects | NR | NR | NR | NR | NR | NR |
| NR | NR | 12.6 ± 4.2 /25.8 ± 4.3 | NR | 6(8.8%)/8(11.8%) | 3(4.4%)/4(5.9%) | 12.6 ± 4.2 d/25.8 ± 4.3 d | NR | NR | NR |
| 6.84 ± 0.62/3.19 ± 0.65 cm2 | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| /−2.0 ± 3.9/−1.6 ± 1.7 cm2 | NR | NR | Amputation and infection (control group) vs osteomyelitis, fever, wound infection, and pulmonary congestion (treatment group.) | NR | 0/1 (3%) | NR | NR | NR | Treatment: 16 Control: 11 |
| NR | NR | 69.44 ± 36.055/NR | No side effect | NR | 19.1%/57% | NR | NR | NR | 0 |
| NR | 74.58 ± 0.35/50.30 ± 0.17(%) | NR | An increase in the area and perimeter of the lesion four patients (antibiotic group) | NR | 3(5%)/7(16%) | 26 ± 13/34 ± 18 d | NR | NR | NR |
Abbreviations: NR, not reported; VAC, vacuum‐assisted closure.