A D A R E S E A R C H P R O F I L E

The Pressure's On

JEFFREY A. STONE, DO, MPH

OccupationMedical Director of Aerospace

Medicine and Associate MedicalDirector for the Hyperbaric MedicineUnit at the Institute for Exercise andEnvironmental Medicine and a staffdoctor at the Wound Care Clinic ofNorth Texas, both at Presbyterian

Hospital of Dallas. Hyperbaric medi-cine consultant to insurance groups

and the Department of VeteransAffairs Hospital in Dallas.

Professional FocusStudying the effect of hyperbaric

oxygen therapy on diabetic wounds.

Outside InterestsStone is an airplane pilot and a scubadiver. He loves classical music andplays the French horn. He's beenmarried for 12 years and has two

sons, David and Daniel.

Research FundingAmerican Diabetes Association

Clinical Research Grant

In his free time, Jeff Stone goes to great heights in this 1931 Germantraining plane (model 131E, Bucker Jungnann). In his research, he goes togreat depths to help people with diabetic foot wounds.

Have you ever gone hiking highin the mountains? You mighthave noticed that the higher up

you went, the more you struggled loroxygen. That's because at higher alti-tudes there's less atmospheric pres-sure, and therefore, less oxygen. Whenyou hiked down the mountain, yourbreathing got easier because the airwas more concentrated and containedmore oxygen.

You might ask yourself what any

of this has to do with diabetes. JeffreyStone. DO, MPH, would say "a lot."Especial ly for people wi th diabeticwounds.

Stone works with people who havechronic foot wounds, that is, woundsthat have gone unhealed for more thantwo months. Many of the people Stonesees have diabetes. On average, thewounds of his patients with diabeteshave been present for 1 1.8 months,

continued on page f>()

Diabetes Forecast May SQ

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A D A R E S E A R C H P R O F I L E

and some have been there for years.Stone thinks that hyperbaric oxy-

gen (HBO) therapy can help thesewounds heal. During HBO therapy, apatient breathes oxygen at increasedatmospheric pressure.

Doctors have used HBO therapyfor over 40 years. It has helped peo-ple recover from carbon monoxidepoisoning, decompression sicknessafter diving accidents, and chronicbone infections. More recently, it'sbeen used for people with soft tissueradionecrosis (when radiation treat-ment for cancer kills the cancer cellsbut also kills the good tissues andblood vessels), failing skin grafts, andsoft-tissue infections. Now Stonewants to add foot ulcers to that list.

"I believe that HBO therapy, whenused with standard foot care on cer-tain types of chronic diabetic wounds,will result in faster healing and feweramputations," Stone says. In a reviewof 501 patient records, reported lastyear, Stone found that those who hadHBO therapy in addition to standardwound care had fewer amputations,even though the people chosen toreceive HBO treatments had biggerwounds and were at higher risk foramputation. (See "High OxygenSaves Feet," Forecast, September1995, p. 30.)

Other doctors aren't so sure thatHBO helps, so Stone is setting out toprove that it does. In a study of over100 people with foot ulcers, Stonewill see if HBO therapy increases thenumber of wounds that heal, helpswounds to heal more quickly, andreduces the number of amputations.

Stone is well prepared for thisstudy because he has had years ofexperience with HBO therapy. Aftermedical school, Stone earned a masterof public health degree from Harvard.He completed a residency in aero-space medicine and a fellowship inhyperbaric medicine at the U.S. AirForce School of Aerospace Medicineat Brooks Air Force Base, SanAntonio. He was then named chief of

the Depa r tmen t of Aviat ion andHyperbaric Medicine at the UnitedStates Army Aeromedical Center inFort Rucker, Ala., where he devel-oped the Army's hyperbaric medicineprogram. He ran that program for twoyears before he joined the hyperbaricmedicine u n i t at the Ins t i tu t e forExercise and Environmental Medicineat Presbyterian Hospital of Dallas in1992, where he does research and hasa clinical practice. He is board certi-fied in aerospace medicine.

Starved For OxygenTo Stone, HBO therapy seems tailor-made for treating certain foot ulcers."HBO is based on precise physiologi-cal principles," he says.

The body needs oxygen to healitself. White blood cells need oxygento fight infections, and tissues needoxygen to repair themselves and makenew blood vessels. Without enoughoxygen, wounds don't heal, and thatcan lead to amputations—some 50,000a year in people with diabetes.

Unfortunately, some people withdiabetes have a hard time gett ingenough oxygen to foot ulcers. Theyhave poor circulation because the largearteries in their legs and feet have"hardened." Hardened arteries are nar-rower than healthy arteries, and bloodmoves through them more slowly.Poor circulation slows down healingbecause wounds don't get enough oxy-gen. Such wounds are called ischemiculcers.

Even when the blockages in theselarge arteries are cleared, some diabet-ic wounds don't heal. It appears thatthe affected area still isn't getting anadequate flow of blood.

Stone thinks HBO therapy wil lhelp people with ischemic ulcersbecause HBO helps oxygen get to thewounded area.

In Stone's study, patients will gointo an HBO chamber. The atmospher-ic pressure will be increased, and thesubjects will breathe pure oxygen. Theeffect: Their tissues will get 15 to 18

60 Diabetes Forecast May 1996

times the normal amount of oxygen.This extra oxygen, asserts Stone, willhelp certain ischemic ulcers heal.

A Researcher With A Bias"I'm a strong proponent of hyperbarictherapy when it's used appropriately,"says Stone. His enthusiasm makeshim a biased researcher. But mostresearchers are. They start experi-ments expecting certain results.

Biases could lead to problems be-cause researchers might unconscious-ly fix the results. For example, Stonemight inadvertent ly assign peoplewith smaller ulcers to get HBO treat-ments and assign people with large,hard-to-heal ulcers to the non-HBO(control) group. If the HBO groupdoes better, would it be because ofthe HBO therapy or because they hadsmaller wounds?

The people in the study might alsobe biased. For example, a patientmight strongly believe that HBO treat-ments will help and is enthusiastic andhopeful when he finds that he's part of

continued on page 62

Total Pressure

At sea level, the pressure of theatmosphere is 760 millimeters ofmercury (mmHg), which is 1 atmos-pheric absolute (ATA) pressure.That's how much force is pushingdown on us.

Air is made up of different gases,and the total pressure of the airequals the sum of the pressures ofeach of the gases. Air is 21 percentoxygen, so the partial pressure ofoxygen in air is 21 percent of 760mmHg, or 160 mmHg.

When the pressure of the atmos-phere is increased to 2 ATAs, thetotal pressure is twice 760 mmHg,or 1,520 mmHg. The pressure ofoxygen is 21 percent of 1,520, or319 mmHg. So even breathing air at2 ATAs will increase the amount ofoxygen you get. But it will also

increase the amount of other gasesyou breathe, such as nitrogen, whichcan make you sick if you breathetoo much of it.

The people in the HBO group inStone's study will breathe 100 per-cent oxygen at 2.4 ATAs (the samepressure found at 45 feet below sealevel) so they'll receive 1,824mmHg of oxygen, or about 11 timesthe amount of oxygen they'd getbreathing regular air.

The pressure doesn't only affectthe amount of oxygen going into thelungs. The pressure on the bodyforces more oxygen to move fromthe blood into the cells of tissues.When a person breathes 100 percentoxygen at 2.4 ATAs, tissues receive15 to 18 times the amount of oxy-gen they'd get if the person werejust sitting in a room breathingregular air.

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A D A R E S E A R C H P R 0 F I L E

the treatment group. His ulcer healsquickly. But was it because of theHBO or because of the patient's enthu-siasm and hope?

Previous studies of HBO therapyhave indicated that it works, but therehas been controversy surroundingthem because of their biases. In some,researchers chose which patients gotHBO treatments. Some subjects knewthey were getting HBO therapy. Thismay have affected the results, whichis part of the reason that some peoplefeel that HBO has not been proven tobe effective.

To protect the results of a studyfrom biases, better-designed studiesare "double-blinded"—neither thestudy subjects nor the researchersknow who is getting the experimentaltreatment.

Stone's study is double-blinded.Subjects will be randomly assigned tothe HBO or control group. All of thesubjects have "treatments" in a pres-surized hyperbaric chamber, but somepeople will breathe 100 percent oxy-gen (the real treatment) and some willbreathe only the amount of oxygen inregular air.

Not Only OxygenPeople in the study will be over the

age of 21, have either type I or type IIdiabetes, and have had non-healingdiabetic wounds for at least twomonths. All of the patients will receivea regimen of standard wound care. Ifpatients have a correctable blockage ofblood vessels, they'll have proceduresdone to correct the blockage beforethey enter the study. Any infectedbone will be removed. Patients will behelped to get their blood glucose levelsclose to normal. They'll be encour-aged to stop smoking, to eat a healthydiet, lose weight if needed, and doexercises that won't put weight on thefeet with the wounds.

Stone emphasizes that HBO can'ttake the place of any of these standardtherapies. "HBO is not a cure-all," hesays, "and it's not even the first treat-ment that should be tried. Many ulcerswill do fine without HBO treatments.But some still won't heal. Then,hyperbaric oxygen therapy should betried. But it still needs to be used as anadjunct to standard foot care."

While continuing with standardwound therapy, each patient will beassigned to either the HBO group orthe control group. People in the HBOgroup will sit in the HBO chamber,and the atmospheric pressure will beincreased to what a diver would feel

Atmospheric pressure in this $2 million chamber can go from the equivalentof 200 feet below sea level to the equivalent of an altitude of 100,000 feet.

62 Diabetes Forecast May 1996

45 feet below sea level. (Stone some-times refers to treatments as "dives.")They will feel pressure changes intheir ears, as they would in a planethat's landing. They'll breathe 100percent oxygen for two 45-minutesessions, with a 5-minute air break inbetween. They'll use masks or hoodsto breathe pure oxygen.

People in the control group willalso go into the chamber, and thechamber will be pressurized. In con-trast to the HBO group, the controlgroup will breathe the amount of oxy-gen they'd get in regular air. They'llget 15 minutes of 100 percent oxygenbefore returning to air pressure at sealevel, which will reduce their risk of

decompression sickness to near zero.While in the chamber, people can

read, listen to the radio, or watchvideos. The chamber is monitored onthe outside by people using advancedcontrols and computer systems, andthere's always a health care profes-sional in the chamber. "I go in everyfew weeks," says Stone. "It's quiet. Idon't bring my beeper. I get to talk tothe patients, or just read."

All patients will have a maximumof 40 treatments during a period ofabout eight weeks while still gettingstandard wound therapy. Stone willassess the wound sites every week. Ifafter 40 treatments a patient's wounddoes not show significant healing,

Stone will see whether the patient wasin the control or the HBO group. If thepatient was in the control group, thepatient will be taken out of the studyand offered HBO treatments.

Stone will follow up with patientsfor one year after the therapy. He willlook at how many patients neededamputations, the number of woundsthat healed completely, and how longit took the wounds to heal. Stone willalso examine the records to see if cer-tain types of people or wounds didespecially well with HBO therapy.

If Stone can prove that HBO thera-py works, there may be a new stan-dard of care for people with diabeticfoot WOUnds. —STAGEY N. WAGES

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