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Fox JD, Baquerizo-Nole KL, Freedman JB, et al. Ankle Range of Motion, Leg Pain, and Leg Edema Improvement in Patients With Venous Leg Ulcers. JAMA Dermatol. 2016;152(4):472–474. doi:10.1001/jamadermatol.2015.5637
Venous leg ulcers (VLUs) affect 2.2% of Americans older than 64 years, costing the US health care system roughly $14.9 billion annually.1 The lower extremity venous system is part of the calf muscle pump, and dysfunction (chronic venous insufficiency [CVI]) can cause ulceration).2,3 Reduced ankle range of motion (AROM), alone, or in conjunction with other factors such as CVI, can lead to calf muscle-pump dysfunction and subsequently to sustained ambulatory venous pressures, which is an integral factor in venous ulcerogenesis.3,4 Patients with VLUs have reduced AROM compared with patients diagnosed with venous disease without ulcers, or those without venous disease. Patients diagnosed with VLUs also have undiagnosed neuropathy.3,5 Compression therapy has been shown to improve healing of VLUs.4 The purpose of this study is to elucidate how compression therapy—standard care for VLUs—affects pain, neuropathy, and AROM, and how these variables relate to each other. We hypothesized that compression will reduce leg circumference and improve pain, AROM, and neuropathy.
With University of Miami institutional review board approval and patient written informed consent, we enrolled adult patients with VLUs without significant ipsilateral arterial insufficiency, uncontrolled diabetes mellitus, or severe infection into a 4-week prospective observational trial. We measured patient wound size, pain, and leg circumference. As previously described,5 AROM was assessed using goniometry, and neuropathy was assessed using the neuropathy disability score (NDS), ranging from 0 to 5 (0 being normal). Patients received standard care with multilayer compression therapy for a mean (SD) of 28 (7) days. Linear regression was performed using GraphPad (La Jolla, CA, 2015).
Ten patients (5 men and 5 women) were enrolled. All had received and tolerated multilayer compression therapy prior to entering the trial. Baseline and 4-week follow-up data are depicted in Table 1. Reduction in leg circumference was associated with improvement in total inversion and eversion AROM (coefficient, −2.0 ([95% CI, −3.7 to −0.3]; P = .03) (Table 2). We found improvement in total dorsi/plantar flexion was associated with reduction in leg pain (coefficient, −2.0 [95% CI, −3.2 to −0.8]; P = .006) and associated with wound pain (P = .05). Initial plantar flexion, dorsiflexion, and inversion and eversion AROM values did not correlate to percent wound reduction (coefficient [95% CI]: −0.42 [−18.0 to 17.1]; 0.76 [−4.7 to 6.2]; 0.68 [−8.4 to 9.8]; −0.81 [−5.9 to 4.3]; P = .96, .76, .87, .72, respectively).
In this 4-week pilot study, 10 subjects with VLUs receiving compression therapy had improved AROM associated with reduction in leg pain and leg circumference. We did not find any association between baseline AROM and 4-week percentage wound reduction. Compression likely reduces venous hypertension and fluid exudation and increases venous return and lymphatic flow, which reduces leg circumference. This may cause decreased interstitial inflammation resulting in decreased leg and wound pain. The decrease in leg and wound pain, along with decreased swelling, may allow for an increase in AROM.
Baseline combined dorsiflexion and plantar flexion and combined inversion and eversion AROM degrees were abnormal in 9 of 10 subjects (normal range, 47°-69°),5 and 6 of 10 (20°-55°),5 respectively, confirming the association of reduced AROM in patients with VLUs.3 Additionally, 6 patients (60%) had neuropathy, consistent with previous findings.5 The lack of improvement in NDS with compression suggests either the nerve damage due to the CVI-induced interstitial inflammatory milieu is possibly irreversible, or the study duration was too short to detect changes.
This pilot study was limited by its small sample size and short follow-up. Larger and longitudinal trials are warranted to further evaluate correlations between AROM, pain, edema, neuropathy, and wound healing. It is possible that interventions aimed to increase AROM may be additive to the care of VLU.
Corresponding Author: Robert S. Kirsner, MD, PhD, Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1600 NW 10th Ave, Rosenstiel Medical Science Building, Room 2023A, Miami, FL 33136 (Rkirsner@miami.edu).
Accepted for Publication: November 13, 2015.
Published Online: January 27, 2016. doi:10.1001/jamadermatol.2015.5637.
Author Contributions: Dr Kirsner and Mr Fox had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Baquerizo-Nole, Van Driessche, Yim, Kirsner.
Acquisition, analysis, or interpretation of data: Fox, Freedman, Liu, Kirsner.
Drafting of the manuscript: Fox, Baquerizo-Nole, Kirsner.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Fox, Freedman, Kirsner.
Administrative, technical, or material support: Baquerizo-Nole, Van Driessche, Kirsner.
Study supervision: Kirsner.
Conflict of Interest Disclosures: None reported.
Additional Contributions: We are indebted to Carol B. Kittles for her regulatory work with the internal review board, as well as Aliette Espinosa, CCRP, our clinical research coordinator. Neither were compensated for their contributions.
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