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Hyperbaric Oxygen Therapy For The Diabetic Foot

Medical information reviewed by: ANDREI BOGDAN, MD, Orthopedics-traumatology doctor

i.php?p=1. Tratamentul hiperbaric in pic

Discover the hyperbaric medicine center opened in our clinic. Centrokinetic has the top-performing hyperbaric chamber in Bucharest, with multiple medical and anti-aging uses. The Baroks chamber has 5 seats, and operates at a constant pressure of 2.5 atmospheres, being fully automated and having protocols for each condition, and can be used individually for each patient. 

Hyperbaric oxygen therapy - benefits

Patients who use the clinic's hyperbaric therapy services benefit from:

  • The only medically accredited hyperbaric therapy chamber in Bucharest, which operates at 2.5 atmospheres (those for aesthetic use go to 1 atmosphere and have no medical benefits).
  • A safe medical procedure, without irradiation, without pain, without other side effects. 
  • The specialized medical team consists of recovery doctors, orthopedists, rheumatologists, neurologists, and neurosurgeons, meaning a multidisciplinary team specialized in all diseases that can be treated with hyperbaric therapy. 
  • Premium conditions at a fair price. Our clinic is recognized for the conditions offered and for the care of each patient. But we do not need to pay exorbitant prices to have access to quality medical services. At Centrokinetic you can find an affordable and fair price. But note that we do not have a contract with the National Health Insurance House (we do not offer state reimbursed services)

Centrokinetic is keeping contact with prestigious clinics and universities in Belgium, the Netherlands, France, and Greece to constantly update treatments to provide patients with the best medical solutions.

What are the effects of oxygen therapy on the body?

  • Decreases inflammation
  • Increases the body's oxygen saturation by 20-30%
  • Increases the body's immunity
  • Increases blood circulation and stimulates the formation of new capillaries
  • Decreases toxins in the body
  • Stimulates the production of new blood cells
  • Increases healing rate

The effect of HBOT on diabetic foot ulcers, Wagner classes 3 and 4, was assessed using a set of real-world retrospective data. The study reported the overall cure rate (74.2%) in the population for more than 2 million wounds.

When a subgroup of patients with grade 3 or 4 Wagner foot ulcers was considered, the cure rate was only 56.04%. The use of HBOT, without filtering for the number of treatments received, improved the cure rate to 60.01% overall. The cure rates for this same subgroup were, however, improved to 75.24% for patients who completed the prescribed number of hyperbaric treatments.
This study will show us the results of hyperbaric oxygen treatment concerning the etiology of the wounds, it will show us the risks if any to give clinicians an indication of when an advanced treatment technique, such as hyperbaric oxygen, should be prescribed. The authors provide data on the healing results of several previous HBOT studies, as well as other advanced methods that have been used in diabetic foot care.
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Introduction

There has been much debate in the literature about the general benefits of hyperbaric oxygen therapy (HBOT) in wound care. Many of the initial studies that led to positive results were performed in hospital settings and thus, not surprisingly, the results did not translate into an outpatient clinical reality. 

The studies also reported various primary endpoints of the results, making comparison difficult. Even when the results were evaluated for wounds of a single etiology, no effort was made to divide patients according to their general clinical condition, or the complexity of the specific wound.

When reporting rates of diabetic wound healing, studies refer to various diabetic foot conditions or diabetic foot ulcers of varying degrees Wagner. In many of these studies, when HBOT is administered, the total number of completed treatments is rarely taken into account, making the impact of therapy difficult to assess.

The main objective of this study is to report HBOT results on diabetic foot ulcers limited and especially for the more complex Wagner classes, 3 and 4, using the largest database in the world. This research aimed to identify a sample of patients with diabetic foot ulcers who demonstrate a significant response to HBOT using a large sample size to guide clinicians when they need to apply complex treatment. 

Materials and methods

The study began by reviewing and updating existing data on diabetes-specific wounds, the action of HBOT techniques, and the final clinical provisions of 682 outpatient wound care centers nationwide between January 1, 2014, and April 28, 2018. 

The time for data inclusion was determined by the availability of aggregated data at the time of analysis. The data were obtained from our clinical database and collected using a specialized data capture system. All participants who order and use HBOT have completed at least a 40-hour course approved by either the Undersea Hyperbaric Medical Society or the American College of Hyperbaric Medicine. All diabetic patients received care only based on evidence-based clinical practice guidelines that are used in all centers.

All patients, whether or not they were offered HBOT, underwent glycemic control and went through all the specific treatment of wound care, benefited from evaluation and revascularization and, if necessary, underwent surgery. All patients, regardless of the etiology of the wound, were evaluated every 4 weeks during wound care treatment to identify patients who were not recovering from conventional treatment.

The next phase of the analysis was to create an analytical subsample of diabetic wounds. All Wagner grade 3 or 4 diabetic ulcers that were located on the foot or toes were evaluated. The decision to use only wounds located on the foot and toes was made to focus the results on diabetic foot ulcers and not on a broader category of diabetic wounds located on the lower extremities (DWLE). As mentioned earlier, most initial HBOT studies were limited to wounds located under the ankle. 

The sample was further limited to cases where only one wound was noted to ensure the ability to accurately identify the ulceration for which HBOT treatment was prescribed, including those in active treatment at the time of study closure. 

The final sample size included 25,562 diabetic foot ulcers. The study reports retrospective observational data on healing and amputation outcomes using a specific framework for measuring outcomes. Also, sample healing results were collected and reported. This allows clinicians to set healing rates in context with other types of wound care cases. Subsequently, the impact of HBOT-specific techniques in wound healing was established.

There are several types of wounds and sores on the legs, and diabetic patients may have ischemic wounds, venous ulcers, or traumatic wounds located somewhere on the lower extremity, which could be caused by diabetes. 

Results

During the study, a total of 2,651,878 wounds were assessed. The healing rate of diabetic foot wounds at the sample level was 74.2%.

There was variability in diabetic foot healing rates, specific to wounds, from 55.3% to 80.6%. Not surprisingly, arterial wounds have shown the lowest cure rates while venous ulcers heal much faster. At this level of stratification, there does not appear to be a major difference in the cure rate for people with various types of wounds and leg ulcers, using HBOT techniques. For the additional study, only patients with a single Wagner class 3 and 4 wounds located on the foot or toe were included. 

Healing and amputation rates are reported for the complete sample of Wagner grade 3 and 4 diabetic foot ulcers in Table 2. Once wound exclusions are applied, the sample is reduced to 19,057 wounds with a cure rate of 56.04% and an amputation rate of 4.09%. 

By comparison, the healing rate of diabetic foot wounds for all etiologies of wounds previously published by Ennis et al was 74.6%. 

In conclusion, the overall cure rate of patients with diabetic wounds can reach 80% and is lower for Wagner classes 3 and 4, an indication of the difficulty of healing for patients with confusing comorbid conditions and emphasizes the importance of risk stratification when reporting results. 

There is a report showing additional outcomes for patients who received at least one HBOT treatment (6,616) compared to patients who did not receive HBOT treatment (18,946). After excluding certain wounds, patients who received HBOT treatment showed a slightly higher diabetic foot healing rate (60.01%) than patients who did not receive HBOT treatment (54.33%), leading to a difference of 9.47%. 
Amputation rates were compared between the two groups, with an amputation rate of 4.16% in the HBOT sample and an amputation rate of 4.06% in the non-HBOT group. 
There is a comparative ratio between patients who have completed treatment and those who have not. Of the 5,742 patients who received HBOT, only 2,597 completed their hyperbaric treatment (45.2%); Under these conditions, of those patients who received a full HBOT program, 75.24% versus 47.44% were cured with a difference of 36.9%. The demographic characteristics as well as the wound characteristics for the two groups (HBO and non-HBO) were also analyzed to further identify the potential impact of the therapeutic intervention. 

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These data explain why therapeutic outcomes are so different and how therapy may lose its effectiveness in the outpatient setting when patients do not follow the full treatment regimen. The two most common reasons why patients gave up treatment is that they decided to do so for unknown reasons or were not satisfied with the progress of treatment. Patients who did not complete the treatment program did only 57% of them and discontinued treatment an average of 40 days after the first HBOT treatment.

Overall, patients who chose to give up without argument completed 40% of the treatment program, while patients dissatisfied with the evolution of treatment brought the program up to 88%. 
Another group that did not complete the HBOT program were those whose wound healed during the treatment program. For obvious reasons, this group had no clinical reason to complete their therapy program. 

When the two groups were not analyzed separately - those who received HBOT treatment and those who did not, a previously noted cure rate of 60.01% was observed. In other words, the study showed a 23% improvement in results when HBOT treatment is applied according to schedule and the overall treatment plan is followed. 

Of course, this assumes that the patient has been medically stabilized, revascularization has been performed if indicated and clinically possible, the infection has been controlled, cleansing, and treatment have been applied during and after HBOT treatment. 

Therefore, future research must include information on the patient's condition to fully appreciate the therapeutic benefit obtained using HBOT techniques. These data can also help determine patients to choose innovative treatments but also support medical staff to evolve and get the best results using multiple protocols and techniques simultaneously. 

This study identifies two critical variables regarding the effectiveness of HBOT in treating real health problems: 
  • Patients must complete the entire general care program in the hospital unit, because HBOT is an adjunct only if there is good care.
  • When HBOT treatment is recommended, it should be followed according to the specific program. 

Discussion

This retrospective study suggests that HBOT may be effective for Wagner's grade 3 and 4 diabetic foot ulcers, which are difficult to cure and demonstrate the complexity of studying therapy using real-world observational data. Specifically, the results emphasize the importance of treatment adherence when analyzing the effectiveness of HBOT. 

Although the cure rate at the population level provides an overview of the effectiveness of wound care centers in general, we must also analyze the results at a more specific level. Velocity ulcer healing rates, for example, are frequently reported without segregation in various clinics. The rate of arterial ulcer healing rarely describes the level and extent of peripheral arterial disease when reporting cure rates. 

Also, methods of determining revascularization are often not a variable considered in the final analysis. Given that HBOT is approved for the treatment of diabetic foot, an extremely heterogeneous group that separates wounds by anatomical location and Wagner grade may provide different results. Variations in diabetic foot ulcer healing rates have been reported based on the medical units in which the treatment was applied, further complicating how the results are interpreted. 

In some studies, the same clinical team provided care using the same protocols in two different hospitals. The first, a small community of 200 beds and the second, a unit of 700 beds. The difference noted in the cure rates at these two centers (73.7% compared to 59.5%) obtained by the same clinicians determines the need to stratify the treatment conditions very well.

There have been several randomized studies that have shown improvements in the healing rate of diabetic foot ulcers. Some extremely quoted articles are described here. Löndahl et al published a randomized study of placebo techniques in 2010. 

The study was performed in an outpatient setting using a multiplace chamber. Patients received oxygen or air at 2.5 atmospheres of pressure. However, investigators included grade 2 Wagner ulcers (24% of cases) in this study, making some comparisons with the present study impossible.

Also, several patients were cured in the present study, and the effect was improved in subgroups. This fact supports the conclusions of this study regarding the total results of the treatments received. The study was designed for 1 year and the significance was obtained at 9 months. 

Kessler and colleagues randomized 28 patients with diabetic foot ulcers who were hospitalized to receive HBOT or standard treatment. Patients were given two HBOT treatments a day, 5 days a week for 2 weeks. All patients had normal vascular examinations before enrollment.

At the end of the 2 weeks, there was a significant reduction in the wound area in patients with HBOT, but at discharge, there was a significant improvement because both groups healed similarly. The impact of HBOT in the first 2 weeks was significant, given that both groups received intense attention and the only differentiated treatment was the use of HBOT. The only question that follows from this study is why the initially different results were lost to the end, and the discharge results were almost identical.

Duzgan et al demonstrated a cure rate of 66% compared to 0% in a hospital that treats infected diabetic foot ulcers. Finally, it was found that the differences were significant between those who received HBOT treatment and those who did not. The hospital location had an impact on diet, treatment, and blood glucose control, all of which were more difficult to manage in the outpatient setting. Also, patients have not been in the hospital for > 1 month, so it is not reasonable for the cure rate to be comparable to an outpatient study. Abidia and colleagues studied patients who have ulcers in their legs but who cannot benefit from the reconstruction of blood vessels and obtained positive results in just 6 weeks compared to 1 year with standard treatments. The daily protocol involved HBOT at a pressure of 2.4, 5 days per week for 30 treatments. 

Interestingly, in this study, even if the size of the ulcers decreased, no complete cure was obtained at 1 year. For this reason, when studies on alternative therapies are made, the analyzed sample must provide complete results otherwise they will not be taken into account.

Kalani and colleagues analyzed 38 patients with irreparable vascular disease and diabetic foot ulcers for a period of 3 years. Patients treated with HBOT reported a cure rate of 76% compared to 48% in the sample that followed only standard treatment. Patients received between 40 and 60 treatments. In all of these studies, there was a positive healing trend in patients who underwent HBOT treatments. The problem with all studies is, however, the variation in the frequency of HBOT treatment, the total number of HBOT treatments, the small sample size, the various care locations that affected the results, and variations of major comorbid conditions, such as infection and vascular condition. Published results of other advanced treatment modalities, e.g ultrasound therapy.

Not all studies have tested positive for HBOT to cure diabetic foot ulcers. As in the literature that assumes a positive impact of HBOT, publications that have not found any effect have limitations. Margolis and colleagues published a study on a large database using information collected from several units. There was an average of 29 treatments administered using HBOT, but no description of cure rates correlated with the number of treatments received. This study in a sample of 6,259 patients failed to demonstrate improved healing for nonischemic diabetic foot ulcers. An article published in 2016 that used a double-fictitious protocol for the treatment of diabetic foot ulcers and HBOT did not lead to any significant reduction in the amputation recommendation. Surprisingly, these patients did not receive any indication for amputation but were simply evaluated by a single surgeon through photographs and a database was created for this purpose. This study was carefully contradicted by many scientists who requested additional information.

The Cochrane study also failed to support HBOT techniques, but noted positive short-term but not long-term wound healing trends and recommended additional high-quality studies to be performed in the future. 

Recent literature describes the risks of using random methods to determine the effects of various modern treatment techniques. A recent study conducted in several centers in the Netherlands evaluated the effect of HBOT techniques on the diabetic foot, obtaining a 12% higher rescue rate of the affected limbs. 

The overall cure rate is reported at 75.9% and decreases to 72.3% when the data set is further modified to include diabetes. When Wagner's 3rd and 4th degree more advanced diabetic ulcerations are used as filters, the cure rate drops to 56.04%. The use of HBOT treatment brings this value up to 60.01%, but when only cases with completed HBOT treatment are evaluated, the cure rate is 75.24%. 

Patients need to know what they are going to be involved in and be serious about following the program for this treatment approach to work. Finally, we need to use big data to help create care algorithms based on the complexity of the patient's clinical problems. The cost of care and recurrence rates are important so that hospitals can provide very good and effective treatment for these patients with complex problems. 

Innovation


This retrospective study is clinically relevant because it suggests that HBOT treatment may be effective for grade 3 and 4 Wagner's ulcers in diabetic foot that are difficult to heal and demonstrates the need to study the real problems with patients seeking treatment.

IN CASE YOU HAVEN'T ALREADY HEARD ABOUT US

Centrokinetic is the place where you will find clear answers and solutions for your motricity problems. The clinic is dedicated to osteoarticular diseases and is divided into the following specialized departments:

  • Orthopedics , a department composed of an extremely experienced team of orthopedic doctors, led by Dr. Andrei Ioan Bogdan, primary care physician in orthopedics-traumatology, with surgical activity at Medlife Orthopedic Hospital, specialized in sports traumatology and ankle and foot surgery. .
  • Pediatric orthopedics , where children's sports conditions are treated (ligament and meniscus injuries), spinal deformities (scoliosis, kyphosis, hyperlordosis) and those of the feet (hallux valgus, hallux rigidus, equine larynx, flat valgus, hollow foot).
  • Neurology , which has an ultra-performing department, where consultations, electroencephalograms (EEG) and electromyography (EMG) are performed. 
  • Medical recovery  for adults and  children , department specialized in the recovery of performance athletes, in spinal disorders, in the recovery of children with neurological and traumatic diseases. Our experience is extremely rich, treating over 5000 performance athletes.
  • Medical imaging , the clinic being equipped with ultrasound and MRI, high-performance devices dedicated to musculoskeletal disorders, and complemented by an experienced team of radiologists: Dr. Sorin Ghiea and Dr. Cosmin Pantu, specialized in musculoskeletal imaging.

Find the latest news by following the Facebook and YouTube accounts of the Centrokinetic clinic.  

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