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Department of Health and Human Services

Topic Suggestion Description

View Topic Suggestion Disposition (PDF) 145 kB

Date submitted: April 21, 2010

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
There is no standard for care pertaining to chronic wounds and ischemic or diabetic ulcers on the extremities of patients.

What is the comparative effectiveness of treating patient’s, including patients who may be medically underserved, chronic wounds or ischemic and/or diabetic ulcers on extremities with various treatment modalities?
Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)
If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:
What is the comparative effectiveness of treating chronic wounds or ischemic and/or diabetic ulcers utilizing the vasodilatation of the microcirculatory system, or the collateral microcirculatory system, produced by non-electric, non-heat producing limb wraps versus controversial common treatment modalities such as the use of hyperbaric chambers, topical solutions, changes in lifestyle, glucose management, various methods of debridement, various types of bandages, self treatment by some medically underserved populations, and in some medically underserved populations, no treatment?
What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)
Adults with diabetes, PAD and/or PVD, or some type of compromised or decreased circulation.
Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
Minorities, Native Americans/Alaskan Indians, Women, remote or rural populations, Elderly, Handicapped, and the uninsured.
Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
Increase patient quality of life, healing chronic wounds or ischemic and/or diabetic foot ulcers, decrease in lower extremity amputations, decrease in cost of healthcare, and reduce the uncertainty among healthcare professionals as to the most effective treatment for these types of ulcers or wounds.
Describe any health-related risks, side effects, or harms that you are concerned about.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?
Which priority area(s) and population(s) does this topic apply to? (check all that apply)
EHC Priority Conditions (updated in 2008)
  • Cardiovascular disease, including stroke and hypertension
  • Diabetes mellitus
AHRQ Priority Populations
  • Low income groups
  • Minority groups
  • Women
  • Elderly
  • Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care
Federal Health Care Program
  • Medicaid
  • Medicare


Describe why this topic is important.
Over 20,000,000 people in the US have diabetes and/or some type of compromised
circulation such as PAD or PVD. As a result, hundreds of thousands of people in the
US suffer from ulcers or chronic wounds on their extremities. Eighty to
eighty-five percent of lower extremity amputations in the US are preceded by an
ischemic or diabetic foot ulcer causing a great reduction in the quality of life of these
people and a great increase in the cost of healthcare in this country. Statistically, one
half of those people receiving a lower extremity amputation will be dead within 36

There is no standard for care for chronic wounds or ischemic and/or diabetic ulcers. It
is important to remove the confusion and the uncertainty commonly experienced by
healthcare professions, such as primary care physicians, but also including specialized
wound care professionals, regarding the most the effective method of treatment for
these types of ulcers or wounds. Also, treating these ulcers or wounds in the most cost-
effective, easily available, patient compliant, and simplest manner, in an attempt to
reduce lower extremity amputations, is critically important to people and payers;
including both private insurance companies and state and federal agencies.

The economic and emotional burden from the staggering cost of chronic wound
treatment and amputations due to lower extremity amputation experienced by
medically underserved populations, such as minorities, Native Americans/Alaskan
Indians, women, remote or rural populations, the elderly, the handicapped, and the
uninsured varies greatly. However, this burden may be most felt by the Pima Tribal
Nation of Arizona whose members, over the age of 30, experience a 50 percent
probability of being diagnosed with type 2 diabetes; which is the highest incidence of
diabetes in the world.

As a result of this research, it is not necessary to establish a standard for care for chronic wounds and ischemic or d
What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)
The mission of reducing lower extremity amputations and reducing healthcare costs.
Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)
If yes, please explain:
Since there is no established standard for care for ischemic or diabetic ulcers, there is
nothing but variation and controversy in what constitutes appropriate clinical care.
For instance, frequency of treatment, types of debridement, the use or type of topical
solutions, and the type and number of layers of bandages, are some, but not all, of the
topics of controversy among clinicians, regardless of level of skill, in what may constitute appropriate clinical care.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?
At the very least, we will provide the results of this research for dissemination to the
Veterans Affairs Healthcare System, State of Connecticut Department of Social
Services, Veterans Affairs Office of Rural Healthcare, Veterans Affairs Quality
Enhancement Research Initiative(QUERI), Indian Healthcare Service, Indian
Healthcare Service Tribal Leaders Diabetes Committee, Mashantucket Pequot Tribal
Nation, and the State of Maine Office of Rural Health and Primary Care.

In addition, we will try to provide the results of this research to Medicare and Medicaid
for their dissemination.

Lastly, we will publish, or submit for publishing, the results of this research in
various medical journals.
Describe the timeframe in which an answer to your question is needed.
As soon as possible. Each day that goes by, lower extremities are amputated that may possibly have been saved.
Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.
This research will reduce the disparity between populations who have or have not
access to specialized healthcare equipment, such as hyperbaric chambers, specialized
wound care personnel, and specialized treatments due to income, race, remote or rural
location, and availability of insurance.
It is important to note that for some vulnerable populations, such as some remote or rural populations and uninsured populations, that there is NO method of treatment for chronic wounds or ischemic and/or diabetic ulcers other than self treatment.

Nominator Information

Other Information About You: (optional)
Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)
  • Health Care Industry (Device, Drug, or Other Manufacturer)
Are you making a suggestion as an individual or on behalf of an organization?
Organization - AGP-MEDICAL, LLC
Please tell us how you heard about the Effective Health Care Program
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