|Year : 2020 | Volume
| Issue : 2 | Page : 335-342
Evaluation of the efficacy of hyperbaric oxygen therapy in the management of diabetic ulcer using Bates-Jensen wound assessment tool
Usha Shukla1, Atit Kumar1, S Anushapreethi1, Shailenera Pal Singh2
1 Department of Anesthesia and Critical Care, Uttar Pradesh University of Medical Sciences, Etawah, Uttar Pradesh, India
2 Department of General Surgery, Uttar Pradesh University of Medical Sciences, Etawah, Uttar Pradesh, India
|Date of Submission||16-Jul-2020|
|Date of Decision||03-Aug-2020|
|Date of Acceptance||10-Aug-2020|
|Date of Web Publication||12-Oct-2020|
Dr. S Anushapreethi
Room no. 208, Type 1, M block, New campus, UPUMS, Saifai, Etawah, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background and Aims: Hyperbaric oxygen therapy (HBOT) has been used as a treatment modality for diabetic wound ulcers recently. The aim of the present study was to evaluate the efficacy of HBOT in the management of diabetic ulcer using Bates-Jensen Wound Assessment Tool. Materials and Methods: A total of 50 patients with diabetic ulcer were included in this prospective, randomized, controlled study. Patients were randomly divided into two equal-sized (n = 25) study groups. Patients in Group CT received only conventional therapy and in Group HT received HBOT along with conventional therapy. Wound ulcers were analyzed on 0, 10th, 20th, and 30th sessions using Bates-Jensen Wound Assessment Tool. Statistical analysis was performed using Microsoft (MS) Office Excel Software with the Chi-square test (level of significance, P = 0.05). Results: The healing recovery rate as changes in the Bates-Jensen Wound Assessment Tool from the 0th to 10th session in Group CT 0.88 ± 1.09 as compared to Group HT 9.96 ± 2.73 improved significantly with P = 0.0001. The grading score recorded from the 10th to 20th session in Group CT 3.73 ± 2.55 as compared to Group HT 10.40 ± 2.47 improved statistically significant, P = 0.0001. The grading score recorded from 20th to 30th session in Group CT 6.16 ± 2.01 as compared to Group HT 6.46 ± 2.19, P = 0.646 was not significant. Conclusion: HBOT has a definitive adjunctive treatment option in healing diabetic ulcers and improving quality of life.
Keywords: Amputations, Bates-Jensen Tool, diabetic ulcer, hyperbaric oxygen therapy, wound healing
|How to cite this article:|
Shukla U, Kumar A, Anushapreethi S, Singh SP. Evaluation of the efficacy of hyperbaric oxygen therapy in the management of diabetic ulcer using Bates-Jensen wound assessment tool. Anesth Essays Res 2020;14:335-42
|How to cite this URL:|
Shukla U, Kumar A, Anushapreethi S, Singh SP. Evaluation of the efficacy of hyperbaric oxygen therapy in the management of diabetic ulcer using Bates-Jensen wound assessment tool. Anesth Essays Res [serial online] 2020 [cited 2020 Oct 29];14:335-42. Available from: https://www.aeronline.org/text.asp?2020/14/2/335/297833
| Introduction|| |
Diabetes is a potential epidemic with major economic consequences in India with more than 62 million., The prevalence of diabetes is predicted to double globally from 171 million in 2000 to 366 million in 2030, maximum increase in India.
The standard treatment options with diabetic ulcers include mechanical and surgical debridement, pressure relief/offloading, and the use of various dressings and topical agents. Advanced care modalities include the use of growth factors, bioengineered tissues, electrical stimulation, ultrasound therapy, hyperbaric oxygen therapy (HBOT), and negative pressure wound therapy.,,
HBOT is defined as breathing 100% oxygen at pressures higher than one absolute atmosphere (ATA) in a hyperbaric chamber. Hyperbaric oxygen increases tissue oxygen tensions, hence promotes wound healing, limits edema, and destroys certain anaerobic bacteria.,,
The present study aims to evaluate the efficacy of HBOT as an adjuvant to standard therapy in diabetic wound ulcer using Bates-Jensen Wound Assessment Tool [Table 1].
| Materials and Methods|| |
After getting approval from the Institutional Ethical Committee (Ethical clearance no. 11/2018, Date: 30/10/2019), written informed consent was obtained from all the patients. Fifty patients of American Society of Anesthesiologists (ASA) physical status Class II/III of both sexes, aged between 35 and 65 years coming as a referral from surgical specialties to the HBOT unit of our institute, were included in this prospective, randomized, controlled study. Patients with active upper respiratory tract infection, lung pathology (emphysema, pneumothorax, history of thoracic surgery, and lesions in X-ray/computed tomography [CT]), Chronic Suppurative Otitis Media, sickle cell anemia, Bates-Jensen Stage 1 and 2 were excluded from the study [Table 2].
Group CT (n = 25): patients received only conventional therapy.
Group HT (n = 25): patients received HBOT in addition to conventional treatment.
Sample size calculation
In the present study, we had two groups comparing wound healing score parameters. We used the following formula to calculate the sample size.
n = 7.9/C × (π4 [1 − π1] + π2 [1 − π2])/(π1 −π2)2
C = 7.9 constant at 5% level of significant with 80% power and 95% confidence interval [CI]
π4 – Estimate of decrease of wound score in the treatment group
π2 – Estimate of decrease of wound score in the control group
n = 7.9 × (64 × 36 + 20 × 80)/(44)2
= 7.9 × (2304 + 1600)/(44)2
= 7.9 × 3904/(44)2
= 7.9 × 2.02
~ 10 at least in each group.
The sample size we had taken was 25 patients in each group.
All patients in both the study groups were investigated with complete hemogram, blood sugar fasting and postprandial, glycosylated hemoglobin, lipid profiles, urinary analysis, kidney function test, and chest X-ray. Ear, nose, and throat examinations were performed by an otorhinolaryngologist to rule out upper respiratory tract infection and inflammation of tympanic membrane. Duration of the ulcer, history of smoking, any associated medical illness e.g. hypertension, coronary artery disease, etc was noted. Local examination of the wound was done using Bates-Jensen Scoring. Size (length and width), number, type of wounds, discharge, vascular insufficiency, or associated varicose vein was recorded.
Group CT entailed daily wound care, including dressing changes and local debridement at the bedside or in the operating room, as well as amputation when indicated. Wound care is standardized throughout the entire study to several different dressing types, for example, simple gauze, sitosterol dressing or alginate, collagen/oxidized cellulose dressing, dependent on the type of the wound (dry, wet, or infected). The wound dressings changed as per the standard care treatment. Infection controls were carried out by clinical follow-up, and by performing culture-antibiograms of surgically obtained specimens to determine appropriate antibiotic therapy. An optimized metabolic control was pursued either with subcutaneous insulin administrations or oral hypoglycemic agents. If a major amputation (above the ankle) was required, the ulcer was considered nonhealed. The decision to amputate is made by a vascular surgeon and by meeting any of the following criteria: (a) persistent deep infection involving bone and tendons, (b) ongoing risk of severe systemic infection related to the wound, and (c) inability to bear weight on the affected limb and pain causing significant disability. Follow-up visits were fixed at 6 months and 1 year following discharge. The study ended when the patient was healed, the foot was amputated, or there was no change.
In the HT group, standard therapy was supplemented by HBOT administration at 2.5 ATA in a monoplace chamber (Make: Perry Baromedical Corporation, USA, Model: Sigma 34 Elite Monoplace Hyperbaric Chamber) for 90 min, 6 days a week. A total of 30 sessions were administered to each patient along with conventional treatment. Duration of treatment in both the groups was conducted for 30 sessions.
Wound ulcer was analyzed on 0, 10th, 20th, and 30th sessions, and assessment of healing in both the groups was noted on the basis of assessment of Bates-Jensen Wound Tool.
Bates-Jensen Wound Tool is described in details [Table 1].
| Results|| |
There was no significant difference with respect to age, sex, body mass index, and ASA physical status [Table 3].
|Table 3: Demographic characteristic of patients in both the groups (mean±standard deviation)|
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The distribution of the severity of wound infection as a moderate and extreme category in both the groups on the 0th session was found to be statistically nonsignificant (P = 1.000) and on the 10th, 20th, and 30th sessions was found to be significant (P = 0.0001). The total grading score at the 30th session was significantly lower in the HT group than in the CT group (P = 0.0001). The patient severity of wound infection in the HT group reduced to 0% and in the CT group reduced to 57.9% [Table 4].
|Table 4: Bates-Jensen wound assessment severity on 0th, 10th, 20th, and 30th sessions|
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The change in total grading score from the 0th to 10th session was significantly higher in the HT group (9.96 ± 2.73) than in the CT group (0.88 ± 1.09) (P = 0.0001) and from the 10th to 20th session was significantly higher in the HT group (3.73 ± 2.55) than in the CT group (10.40 ± 2.47) (P = 0.0001) and from the 20th to 30th session was not significant as the HT group (6.16 ± 2.01) and CT group (6.46 ± 2.19) (P = 0.646) [Table 5].
|Table 5: Comparison of changes in Bates-Jensen Wound Assessment Tool evaluation between CT and HT groups|
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The total grading score did not show any change from the 0th to 10th session within the CT group (P = 0.574). However, a significant decrease in total grading score was observed between the 10th and 20th sessions (P = 0.004) and also between the 20th and 30th sessions (P = 0.0001) [Table 6].
|Table 6: Comparison of changes in Bates-Jensen Wound Assessment Tool evaluation within CT group|
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The total grading score decreased significantly from the 0th to 10th session within the HT group (P = 0.0001). Similar findings were also found for other sessions (P = 0.0001) [Table 7].
|Table 7: Comparison of changes in Bates-Jensen Wound Assessment Tool evaluation within HT group|
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The average hospital length of stay among participants in Group HT was 33.68 days and 58.44 days for participants in Group CT. The result was found statistically significant favoring the Group HT (P = 0.018) [Figure 1].
| Discussion|| |
Diabetes is a serious chronic disease that requires special attention. About 415 million people have diabetes globally which accounts for 1 in every 11 people. The world's second largest diabetic population was India with approximately 69 million people. Approximately 15% of all people with diabetes are affected with ulcer during their lifetime. Wound healing had been shown to be delayed in patients with diabetes and particularly in patients with diabetic ulcers. Peripheral neuropathy, peripheral vascular disease, and poor glycemic control in conjunction with minor foot trauma increase the likelihood that patients with diabetes will develop ulcers. Between 5% and 10% of diabetic patients have or have had such ulcerations, with injuries.
Treatment modalities used in diabetic foot ulcer can be common treatment options such as debridement (mechanical, surgical, autolytic, enzymatic, and biological by means of maggots), pressure relief/offloading techniques (shoes, half shoes, sandals, insoles, in-shoe orthosis, and socks) and various dressings, and topical agents (hydrocolloids, hydrogels, foam, films, and silver-impregnated dressings) are used for wound closure and reepithelialization. Newer modalities for advanced care include the use of growth factor (platelet-derived growth factor, fibroblast growth factor, vascular endothelial growth factor, insulin-like growth factor, epidermal growth factor, and transforming growth factor), bioengineered skin (Apligraft, Dermagraft, and oasis), electrical stimulation, ultrasound therapy, HBOT, and negative pressure wound therapy., Multiple modalities are practiced to promote healing in diabetic ulcer patients, but HBOT may prove to be useful when these modalities fail or are unavailable.
HBOT is a treatment option for diabetic ulcer, where the patient inhales 100% oxygen in a pressurized chamber (2–3 ATA). Hyperbaric O2 stimulates angiogenesis and increases the fibroblast proliferation and collagen production, leading to an increase in tensile strength of the wound.,, The increase in O2 tension produced by HBOT, which persists for several hours after therapy, is responsible for angiogenic properties of HBOT. The high oxygen tension (≥30–40 mmHg) produced by HBOT causes superoxide enzymes to act more rapidly on both aerobic and anaerobic bacteria, thereby demonstrating the bactericidal and bacteriostatic effects of HBOT. Furthermore, HBOT has been shown to have synergistic effects with many antibiotics such as aminoglycosides, trimethoprim, nitrofurantoin, and sulfisoxazole. In addition, during HBOT, hyperoxic vasoconstriction occurs which leads to reduced capillary pressure and increased vascular permeability resulting in decreased transcapillary fluid transfer and an increase in extravascular fluid resorption which reduces lower extremity edema. The intermittent reoxygenation across the barrier formed by edema and poor perfusion maintains cellular integrity and function which can help in salvage of marginally perfused tissue. Hyperbaric O2 causes reduced platelet aggregation, improved tissue microcirculation, and diminished metabolic disturbances. These properties along with increased dissolved O2 in plasma lead to better oxygenation of hypoxic tissue, where red blood cells cannot reach. Thus, HBOT is known to improve antibacterial defenses, increase blood flow, reduce edema, maintain tissue oxygenation, stimulate fibroblast and collagen production, and prevent lipid peroxidation.
Sharari et al. conducted the study of Hyperbaric Oxygen: Silver Bullet for Diabetic Foot Ulcers in 82 patients and concluded that complete healing of the index ulcer was significantly faster in hyperbaric group 50% in comparison to 29% of those treated with conventional wound care. Two major amputations were performed in the HBOT group as compared to 3 cases in Group B; all of them were Wagner Grade IV (P < 0.01).
Ruke and Agarwal  studied in 49 patients in the control group and 48 patients in the HBOT group. The infection recovery rate in the study group was 79.06% (34 out of 43) and 47.61% (20 out of 42) in the control group. Amputations were performed in 20.83% (10 out of 48) and 63.26% (31 out of 49) patients in the study and control groups, respectively. These results were statistically significant (P < 0.05), favoring the study group. Similarly, the results were found in our study, where we conducted 30 sessions of HBOT among 25 patients. After the 30th session, the final grading scores were 41.42 ± 4.17 and 20.58 ± 3.05 in Group CT and Group HT, respectively (P = 0.0001). The severity of wound infection rate in the HT group reduced to 0%, while in the CT group, 57.9% had severe wound infection (P = 0.0001). Thus, in Group HT, healing of the ulcer was significantly faster as compared to Group CT which is similar to the observations made by Faglia et al., Stoekenbroek et al., and Londhal  that HBOT causes the improved rate of complete healing at 1-year follow-up.
With regard to amputation in the present study, the HT group had only one patient with severe infection who underwent amputation, while in the CT group, more patients underwent amputation making total amputation of 6 (24%). All the amputations which took place in our study had extreme severity ulcers. Our results demonstrated the beneficial effects of HBOT in preventing amputation. Liu et al., in a meta-analysis, have shown that the rate of healing and quality of life is improved and the risk of major amputation is reduced in a diabetic patient when we give HBOT. We also found similar results as Liu et al., with reduced amputation ratio in Group HT than standard therapy Group CT. Margolis et al. concluded that hyperbaric O2 therapy neither improves the likelihood of wound healing nor prevents amputation in diabetic patients with foot ulcer having contrary outcome to the present study attributable to different methodologies between two studies.
Michael S. Flood et al. in 2008 studied in 70 diabetic patients which the HBO group received a mean of 38.8 sessions of HBO therapy. HBO therapy was administered twice daily, 5 days per week for 2 weeks, and each session lasted 90 min at 2.5 ATM. After completion of HBO therapy, the decrease in ulcer size was 41.8% in the study group and 21.7% in the control group (P = 0.037). The difference in healing rates between the groups was no longer significant at 4 weeks. In another study, 18 patients received 30 sessions of HBO therapy. Healing was achieved in 5 of 8 ulcers in the treatment group and 1 of 8 ulcers in the control group. The decrease of the wound area was 100% in the treatment group and 52% in the control group (P = 0.027). They used the transcutaneous oximetry and identified that the patients benefited from HBO therapy. In our present study, in the HT group, standard therapy was supplemented by HBOT administration at 2.5 ATA in a monoplace chamber for 90 min, 6 days a week, 30 sessions. In Group CT, 57.9% (11 patients) and, in Group HT, 0% had severe wound infection (P = 0.0001). Thus, HBOT therapy of daily session showed a significant improvement (P = 0.0001).
The most common complication during HBOT is barotrauma, usually of the middle ear, external and inner ear, air sinuses, gastrointestinal tract, and tooth cavities. Pulmonary barotrauma arise as a result of cavitary or fibrotic lesions in the lung parenchyma. The development of acute CNS oxygen toxicity (known as Paul Bert effect) leading to lowering of seizure threshold and precipitation of seizures. Prolonged exposure to lower pressures of oxygen could cause pulmonary oxygen toxicity (known as Lorrain Smith effect) leading to reversible pulmonary restrictive changes. Thus, in our study, as part of a protocol, patients are given an air break during sessions in order to prevent the development of pulmonary oxygen toxicity. Development of reversible myopia and clouding of preexisting cataracts are other complications of HBOT. The other complications are anxiety, claustrophobia, high blood pressure, hypoglycemia and pulmonary edema.
In HBOT, Faglia et al., Kessler et al., Fedorko et al., and Londahl  found barotraumatic otitis and hypoglycemia as complications. Kalani et al. and Londahl  found cataracts. In the Londahl study, myringotomy with tube placement due to pain caused by the inability to equilibrate air pressure through the Eustachian tube More Details was performed. In the current study, the comparison of complications such as ear discomfort and hypoglycemia between the HT and CT groups was found (P = 0.110 and 1.000 nonsignificant).
Kalani et al. found that, on average, the time to heal in the HBOT group was 15 ± 7 months (range, 3–30 months) and in the standard care group was 15 ± 4 months (range, 8–18 months). The current study, the comparison of complications such as ear discomfort and hypoglycemia between the HT and CT groups was found (P = 0.110 and 1.000 nonsignificant) [Table 8]. Londahl et al. showed that, at 3 and 6 months, there was no difference in ulcers healed between the HBOT and standard care groups. However, at 9 and 12 months, there was a significant difference in ulcers healed between the HBOT and standard care groups (P < 0.01). At 9 months, about 57% of ulcers were healed in the HBOT group compared with about 19% in the standard care group. At 12 months, about 61% of ulcers were healed in the HBOT group compared with about 27% in the standard care group. Ruke et al. found that the average hospital length of stay among the HBOT group was 30.68 days and 52.4 days for participants in the non-HBOT group (P < 0.05). In our study, the average length of hospital stay in Group HT was less than Group CT (33.68 and 58.44 days) (P = 0.018).
The healing rate in our present study as changes in the Bates-Jensen Wound Assessment Tool from the 0th to 10th session in Group CT 0.88 ± 1.09 as compared to Group HT 9.96 ± 2.73 improved significantly with P = 0.0001. Grading score changes from the 10th to 20th session in Group CT 3.73 ± 2.55 as compared to Group HT 10.40 ± 2.47 improved statistically significant, P = 0.0001. Grading score changes from the 20th to 30th session in Group CT 6.16 ± 2.01 as compared to Group HT 6.46 ± 2.19 P = 0.646 was not significant.
Currently, therefore, we can say that a lot of data available from international studies support the fact that hyperbaric oxygen is an excellent and valuable support in the healing process in patients with ulcer.
The cellular and biochemical effects of oxygen have strengthened the rationale for its use in patients with chronic wounds. HBOT was started as a treatment modality for the management of numerous indications. In diabetic foot ulcers, HBO therapy can be a valuable adjunct to conventional treatments. It appears to accelerate the rate of wound healing, reduces the need for amputation, and increases the number of wounds that heal completely. The management and treatment of foot ulcers in diabetic patients often require months of medical and surgical therapy, but if HBOT is associated, the healing process takes place in less time.
| Conclusion|| |
We conclude that HBOT is effective as an adjunct to standard treatment in the management of diabetic ulcers by improving the rate of ulcer healing, better control of infection, and shortening the hospital stay.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]