1. Diabetic Lower ExtremityComplications, Fear of Falling and Associated HbA1c Levels:
A Cross-Sectional Study of the East HarlemPopulation
Garry Shtofmakher1, Roger Kilfoil1, Adam Rozenstrauch1, Meenakshi Das Lala5, Matthew Weintraub2, Michael Rothstein, MSN3, Anthony Iorio, DPM,MPH4
New York College of Podiatric Medicine (NYCPM)
1
4thYear Student at NYCPM Class of 2015, 2
2nd Year Student at NYCPM Class of 2017, 3
Clinical Instructor at NYCPM, 4
Associate Professor and Chair, Department of Community Health and Medicine; AssistantDean for Continuing Medical Education,5
Weill Cornell Medical College
BACKGROUND
● Hemoglobin A1c (HbA1c) levels used to measure patients’ blood
glucose levels over 120 days
● Although more costly to quantify than fasting blood glucose
levels, HbA1c might be a more reliable diagnostic and prognostic
indicator for specific podiatric comorbidities
● One of the main risk factors for the development of diabetic foot
ulcers was HbA1C >9% (1)
● Data suggest that the early detection of diabetic foot
complications could reduce the prevalence of ulceration (2)
● Therefore, glucose control is important for the prevention of
diabetic complications
● Preventative measures are key during discussions of the
financial implications of diabetic feet in a hospital setting
● Ulcers account for 1 in 5 diabetes-related hospital visits (3)
● The rate of readmission (for any reason in the same calendar
year) in patients with diabetic foot ulcers was 33.4% in 2008 (4)
● It is estimated that diabetic care accounts for ~25% of hospital
costs
● The pathogenesis and the podiatric implications of diabetes
mellitus are poorly understood (5)
● A better understanding of the co-morbidities and financial
burdens of this global illness, particularly within the podiatric
community, could improve care in the diabetic population and
potentially reduce healthcare spending
● The primary aim of this study was to correlate HbA1c levels with
the podiatric manifestations most commonly encountered in the
clinical setting
● This study was the first to survey HbA1c levels in the East
Harlem population presenting to the Foot Clinics of New York
(FCNY) and correlating the resulting data with various podiatric
manifestations
● These analyses will determine if HbA1c is a positive predictor of
the lower extremity complications commonly manifested in
diabetes
● A secondary objective was to investigate if the progression of
diabetes-related complications had any affect on the fear of
falling
Figure 1. The diabetic pedal manifestations in the study subjects.
Figure 2. The research protocol algorithm.
Figure 3. The relationship between mean HbA1c levels and the
total number of podiatric manifestations. There was a statistically
significant difference in HgA1C ( HbA1c ) levels between groups
(P = 0.027).
Figure 4. The correlation HbA1C levels and the total number of
podiatric manifestations.
Table 1. Demographic characteristics of the study subjects.
MATERIALS AND METHODS
● This study was reviewed and approved by New York College of
Podiatric Medicine IRB
● Prospective subjects were recruited if they reported an
International Classification of Diseases (ICD) code consistent
with diabetes using electronic medical records
● Subjects were enrolled if they expressed a desire to participate,
conformed with the inclusion and exclusion criteria, and provided
informed consent
● Asummary of the study protocol is shown in Figure 2.
● The lower extremities of all subjects were examined using a
comprehensive checklist based on the common symptoms
● HbA1c levels were then measured using a HbA1c measuring
device.
● Data were analyzed statistically using SPSS Version 20 (IBM,
Armonk, NY)
● Multiple statistical models were used, including
● One-wayANOVA
● Correlations and regression analysis
● The primary outcomes were HbA1c levels and the duration of
diabetes
● The secondary outcome was Modified Falls Efficacy Scale
(MFES) score, which was used to measure the risk of falling
● P < 0.05 was considered to indicate statistical significance
RESULTS
Demographics of the Study Population
● Atotal of 38 patients were enrolled at Foot Center of New York
● The mean number of podiatric manifestations was 4.43 (SD =
62.35)
● The mean HbA1C level was 8.23% (SD = 1.94)
● Most subjects were male andAfricanAmerican
● The mean MFES score was 8.19 (SD = 2.5)
Relationships Among Variables
● Several predictors of podiatric manifestations were examined,
including
● Mean MFES score
● Age
● Concurrent treatments for neuropathy
● HbA1C levels
● Correlational analyses revealed that the total number of podiatric
manifestations was:
● Not related to concurrent treatments for neuropathy (r= −0.135, P
= 0.420)
● Not related to MFES score (r = −0.161, P = 0.321)
● Age was also not a significant predictor of podiatric
manifestations (r = −0.137; P = 0.399)
● Regression analyses revealed that the duration of diabetes did
not predict podiatric manifestations (B = −0.019, beta = 0.075;
SE = 0.04;, P = 0.669)
● Regression results also indicated that mean MFES score did not
predict HbA1c levels (B = 0.048; beta = 0.063; SE = 0.125; P =
0.706).
The Ability of HbA1C to Predict Podiatric Manifestations
was no
podiatric
● Simple correlational analyses revealed that there
correlation between HbA1C and the number of
manifestations (r = 0.24; P > 0.05; Figure 4)
● Several follow-up regression analyses were performed to assess
the ability of HbA1c to predict podiatric manifestations when
controlling for individual parameters such age and duration of
diabetes
● HbA1C did not predict number of podiatric manifestations after
controlling for controlling for
● Age and diabetes duration (B = 0.140; beta = 0.124; SE = 0.245;
P = 0.572)
● Age alone (P = 0.290)
● Diabetes duration alone (P = 0.255).
The Effect of Neuropathy Drugs on Mean MFES Score
● Independent t-tests indicated that a subject’s mean MFES score
was influenced by concurrent neuropathy drugs
● Participants receiving neuropathy drugs (M = 6.1) exhibiting a
significantly lower MFES score than did participants not receiving
neuropathy drugs (M = 9.085; t = −3.663; P < 0.001).
The Effect of Neuropathy Drugs on HbA1C Levels
● Finally, data were analyzed to determine whether concurrent
neuropathy drugs could predict a participant’s Hb1AC level
● The results of t-tests indicated that the HbA1c levels of participants
receiving neuropathy drugs (M = 7.566) did not significantly differ
from those not taking neuropathy drugs (M = 8.511), although there
was a trend (t = −1.284; P = 0.208)
CONCLUSIONS
● The podiatric manifestations of patients with diabetes in East
Harlem are wide-ranging
● The two most common findings were nail and skin disorders, which
are both considered to be precursors of infections and amputations
● These are not to be overlooked given their high financial and
quality-of-life implications on individuals with diabetes, particularly
elderly and immunocompromised patients
● The effects of neuropathic drugs were assessed regarding the fear
of falling
● MFES score is a strong indicator of falling in neuropathic diabetics
● Since healthcare in the USA is shifting toward preventative
medicine, finding more cost-effective ways to deliver care for
diabetic patients is crucial
● Predictive tools could help reduce the economic burden of diabetes
● This study assessed the ability of HbA1c to predict the total number
of podiatric manifestations in diabetic patients
● Surprisingly, HbA1C was not a good predictor of the number of
podiatric manifestations
● The weak correlation between HbA1c levels and the total number of
podiatric manifestations might be due to the small sample size
● Nevertheless, these findings do not rule out the potential value of
HbA1C as a predictor of lower extremity complications
● The ANOVA results revealed that between groups of total number
of podiatric manifestations there was a robust effect seen by the
HbA1c number (P = 0.02)
● Future studies should examine the potential of HbA1C for
predicting lower extremity complications
● Although HbA1C levels might be a weak prognostic indicator for
predicting diabetic lower extremity complications, they might be
useful in other clinical situations
REFERENCES
1. Lavery LA, Armstrong DG, Vela SA, Quebedeaux TL, Fleischli JG. Practical criteria for
screening patients at high risk for diabetic foot ulceration. Arch Intern Med. 1998 Jan
26;158(2):157-62.
2. Lipsky BA, Berendt AR, Deery HG, Embil JM, Joseph WS, Karchmer AW, et al. Diagnosis
and treatment of diabetic foot infections. Clin Infect Dis. 2004 Oct 1;39(7):885-910.
3. Bild DE, Selby JV, Sinnock P, Browner WS, Braveman P, Showstack JA. Lower-extremity
amputation in people with diabetes. epidemiology and prevention. Diabetes Care. 1989
Jan;12(1):24-31.
4. Margolis DJ, Malay DS, Hoffstad OJ, Leonard CE, MaCurdy T, Tan Y, et al. Economic
Burden of Diabetic Foot Ulcers and Amputations: Data Points #3. In: Data Points Publication
Series. Rockville (MD): ; 2011.
5. Litzelman DK, Marriott DJ, Vinicor F. Independent physiological predictors of foot lesions in
patients with NIDDM. Diabetes Care. 1997 Aug;20(8):1273-8.
SPECIAL THANKS
A special thanks to the New York College of Podiatric Medicine for helping us fund our trip to the
30th Annual Clinical Conference on Diabetes. A special thanks to Dr. Eileen Chusid, PhD,
Dr. James Ford, PhD, Dr. Khurram H. Khan, DPM, and Mr. Paul Tremblay, MLIS, MA for
providing their expertise, and guidance in the preparation of this poster. A special thanks to
members of the NYCPM Class of 2015 for their assistance with patient recruitment.