Jayesh B. Shah, MD, Medical Director at Northeast Baptist Wound Care Center talks about diabetic wounds and how shockwave therapy can help.
Interview conducted by Ivanhoe Broadcast News in December 2018.
What is involved in the process of hyperbaric chambers and how is that difficult for patients or good for patients?
SHAH: Hyperbaric oxygen therapy has been there for more than 150 years. It started back when patients were treated with diving injuries like decompression sickness, and then it was found that hyperbaric oxygen therapy was also useful in diabetic foot ulcers, many other indications including infections and specific bone infections. During Hyperbaric Oxygen Therapy, a patient breathes 100% oxygen under pressure. In most clinical indications, during hyperbaric oxygen therapy, the pressure is set to 2 atmosphere or 2.5 atmosphere depending on the patient’s condition and it is given for 90 minutes. During hyperbaric oxygen therapy, oxygen systematically goes to the areas that do not have much oxygen. Some diabetic patients do not have a good blood supply so oxygen can help those patients with the healing process.
So the oxygen actually gets right into the tissues and does it stimulate the tissues to heal or how does that work?
SHAH: Diabetic wounds are hypoxic, which means that they have low oxygen. If your oxygen is low, then your white blood cells or leukocytes works at 50% of your capacity. It’s a normal physiology. If you are using hyperbaric oxygen therapy, your cells get the oxygen that is required for them to function normally. Even for collagen synthesis, oxygen is needed. The process for collagen synthesis is to hydroxylate amino acids like proline and lysine and oxygen is needed in this process. Oxygen is useful in higher doses to fight infections and to help with the healing process mainly in diabetic patients.
Is any wound hypoxic or just diabetic wounds? Are they deeper wounds or how are they different?
SHAH: Most wounds will be hypoxic but diabetic wounds are very hypoxic just because diabetic patients have large vessel and small vessel disease. The way I explain this disease to my patients is like having a tree with big and small branches. In diabetes, patient can have a disease in the big branch (big blood vessels) and small branches (small blood vessels). The problem with diabetics is that the small branches are also diseased which causes hypoxia that cannot be corrected by vascular procedures or vascular surgery. And that’s why having hyperbaric oxygen therapy really helps them.
Do they do hyperbaric and the new technique or strictly the new one?
SHAH: Right now we are doing a clinical evaluation of this new technique called Acoustic Shock Wave Therapy because it was recently approved by the FDA and we are using it to really know whether it is making a difference. The acoustic shockwaves delivers pressure pulses to the tissue around and on the wound to stimulate healing. This stimulation helps with regeneration of the tissues. It also helps with new vascularization to create new blood vessels mainly in diabetic microvascular disease. Although programmable, the technology basically gives 240 – 360 shocks per minute. The treatment usually lasts from two to four minutes and it’s not really complicated. It’s pretty easy. When you use this therapy around the wound it improves the perfusion. So right now we don’t do both therapies together. If patients are receiving hyperbaric oxygen therapy then they are not getting shock wave therapy. Hyperbaric oxygen therapy indications that are approved by insurance are pretty limited. So a lot of the wound patients who do not qualify for hyperbaric oxygen therapy, this shockwave therapy is a good alternative for those patients with wounds which are not healing.
And that’s an important distinction because of the payment by insurance companies.
SHAH: Right.
What’s the comparison between hyperbaric and the new shockwave therapy in terms of cost?
SHAH: For hyperbaric oxygen therapy, the cost depends on the location where you’re receiving the hyperbaric oxygen therapy at. Hospital-based facility cost is higher than office based facility and I don’t have the exact numbers. But you’re looking at around $500 to $1,000 per treatment in the hospital setting. The shockwave therapy costs are still unknown. Private insurance payers and CMS are still working on how much they should pay for this treatment.
Ease of usage – hit on that a little bit.
SHAH: Time is the main factor. Since the treatments are done as a part of the patient’s visit, shockwave therapy only takes 3-4 minutes compared to hyperbaric oxygen therapy which takes 90 minutes. In a diabetic wound patient, most clinical studies have shown that at least 30 Hyperbaric Oxygen Therapy treatments are needed to see an improvement. We cannot compare these two treatments as they are two different technologies. There are very specific indications for hyperbaric oxygen therapy and very specific indication for shockwave therapy. The shockwave therapy is just approved for diabetic foot ulcer while hyperbaric oxygen therapy can be used for many different conditions and severe diabetic wounds, bad infections, necrotizing infection, carbon monoxide poisoning, and decompression illness, radiation injury, so the use for hyperbaric oxygen therapy has multiple indications and for more severe infections or severe wounds. While shockwave therapy is only approved for diabetic foot ulcers, at the present time, most insurance carriers only approve HBO therapy for Wagner Grade 3 and Grade 4 Diabetic Foot ulcers. So for Wagner Grade 2 or Grade 1 Diabetic Foot Ulcer, we are using shockwave therapy.
Would you look at the shockwave therapy as almost being a preventative measure because you’re going to catch it at one or two rather than three or four?
SHAH: Well, we cannnot prevent it because we are going to be treating the ulcer because it is not healing. Prevention is preventing someone from getting an ulcer. But if we can treat Wagner grade 1 and 2 ulcers early and if we can heal them at that level then that will greatly help these patients. Patients with open ulcer are always at a risk of getting infection and amputation.
Does the patient feel anything?
SHAH: It creates some noise, but other than that they don’t really feel it because we are putting it in and around the wound. I’ll show it to you in one of our patients but it really does not cause any pain. It’s very easy. Most patients feel like nothing happened. They felt very comfortable. If they are uncomfortable with the noise, we may give them ear plugs.
So you had it now for about 30 days. And as a physician, what is it like for you? How do you feel?
SHAH: I feel pretty good about it because the first patient we treated is already healing. We did four treatments and we’re going to be discharging the patient. The patient was having a hard time healing and was going to need an amputation but we were able to heal and save that foot. So I see very promising results from my initial clinical evaluation.
And there are only ten other places or ten total that are actually using this?
SHAH: Right now, this is the first one in San Antonio. They say this is the first wound center in Texas. And I think what I heard is around 10 to 15 throughout the nation that they have this technology right now.
This is special to have this. How long do you think you’ll be utilizing it before you’re completely comfortable with using it on your patients?
SHAH: I feel comfortable using it now and I already have six patients on it right now.
Are they all improving?
SHAH: Yes, some patients are showing some improvement with this technology, the others are getting their first or second treatment so we are still in the process.
How do you actually see improvement? Is it just the wound shrinking?
SHAH: Well, as the wound heals, we start seeing some good granulation tissue, like more red tissue coming in the wound bed. Also, when we see these patients on a weekly basis, their wound size will go down, the depth will go down and eventually there will be skin over it.
Do you hope that this becomes a mainstay and a fixture here? Where does it go from here within the medical community?
SHAH: Yes absolutely. There is already a randomized trial so that is why FDA approved it. It’s already been proven that it is effective in helping diabetic wounds to improve the blood supply and help with the healing. But the clinical evaluation is being done in multiple sites for the leaders who have been in wound care for a long time, for their opinion on this technology because it’s a completely brand new technology. It’s kind of a breakthrough compared to what we had so far in wound care. So having our opinion from leaders through out the nation will help formulate what would be the best kind of patients that we can use this on. And then it will also depends on what Center of Medicare and Medicaid Services (CMS) decide from the payment standpoint of how that’s going to work out for the patient as we go along.
And often in medicine something leads to something else. Like HBO Therapy came from treating the bends. Did Shock Wave therapy stem from the gallbladder stones?
SHAH: This technology has been around for a while. If you have heard about lithotripsy, that was used for gallstones. And it’s been very successful. It’s being still used for that. And then they found a lot of use for non-union fractures and bone healing, and recently now they’re finding a diabetic foot ulcers usage with that. So yeah. That’s like any other technology that you find using one condition and then you start seeing that wow, it can help in other conditions, too, which definitely needs help. Like diabetes ulcers are so common and so costly if you look at nationwide and look at the amputation rate, it’s so high. Globally every 30 seconds someone gets amputated throughout the world. It’s a pretty staggering statistic. Anything we can do to help those diabetic foot ulcer patients is good. You know, any new technology that comes, we always want to look at it and make sure if it’s gonna help our patients then it’s really great.
Time frame wise, once you as a leader evaluate this and publish or get your findings back, how long will it take before you think this is widespread?
SHAH: I think it’s not going to be long. Seeing the ease of use and depending on how effective this technology is going to be in our clinical evaluation, I think it’s going to be three to six months that it’s going to be widespread.
And San Antonio I think is a hotbed of diabetes. Sometimes I think people don’t understand the severity of diabetes.
SHAH: San Antonio has a pretty high amputation rate and we feel it’s also because of social determinants of health because a lot of times some of our community have a problem seeing a doctor, have trouble with transportation, they don’t have insurance. Texas has a very high uninsured rate also. And then the diet, of course. That definitely comes into play. Not having housing; those kinds of social determinants really determines how they’re going to do. If they’re not able to see a doctor for prevention or for treatment, then they’re going to have a worse outcome.
Can you explain to people how simple this is so that they’re not intimidated about seeking this out?
SHAH: Yes, I think it’s very easy to use. Again, seeing a doctor in a white coat and if they don’t even have a name, it is called white coat syndrome. Some people get a little fearful of seeing a doctor. But we are here to help. It’s really evaluating your wound and seeing what is the best therapy for you. Some of these treatments may not be for you, so as a physician we can decide what is good for you. There are many different things out there for non-healing wounds. And that’s good news. You can do a lot of things now. We have bioengineered skin, which also helps with the healing, hyperbaric oxygen therapy. And now this new shock therapy, which is really very easy to use. Most patients so far finds this technology very easy usually after first treatment they say that “This is easy”. I can do this because it just takes three to four Minutes. It’s not going on for two hours like the hyperbaric oxygen therapy. It doesn’t take a lot of their time from their life. It doesn’t hurt. So patients really like it. They love to do this treatment on a weekly basis.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Natalie Gutierrez, PR Baptist Health
210-260-7250
Natalie.gutierrez@baptisthealthsystem.com
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