Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression

Results of a Randomized Controlled Trial

Oscar M. Alvarez, PhD; Lee Markowitz, DPM; Rachelle Parker, MD; Martin E. Wendelken, DPM, RN

Disclosures

ePlasty. 2020;20(e6) 

In This Article

Materials and Methods

Study Objective and Ethics Statement

The purpose of this study was to assess the safety and effectiveness of IPC plus standard of care static compression versus standard of care static compression alone for the treatment of chronic VLUs. This study was conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki (2013), Title 21, Parts 50, 54, 56 of the US Code of Federal Regulations. Study stopping rules included stopping the study at the discretion of the principal investigator if subject safety was of concern or at the subject's request.

The study protocol, investigators, and consent documents were reviewed and approved by an accredited institutional review board (IRB) (Calvary Hospital IRB, Bronx, NY), and all patients provided written informed consent before participating in the study. This study was registered at ClinicalTrials.gov as NCT02750280.

Study Design and Study Population

The study was a prospective, randomized-controlled, parallel-group, comparative trial. Eligible subjects aged 18 to 85 years were randomly assigned to receive either control treatment, consisting of multilayer compression bandage therapy alone or IPC therapy plus compression bandaging. Subjects were followed up to 12 months for analysis of safety and efficacy. Endpoints were prospectively set at 8 months. Subjects were entered into the study after informed consent was obtained. Those who qualified were assigned to either the IPC or control treatment group according to a computer-generated randomization schedule. A total of 65 subjects were screened and 52 subjects were treated, with 27 randomized to compression bandage therapy alone (control) and 25 to IPC therapy. The ulcers were secondary to venous insufficiency, had to be open for a minimum of 1 year, had to be larger than 20 cm2, and the degree of local wound pain had to be more than 6 on a visual analog scale (VAS) of 0 to 10. Significant arterial insufficiency had to be excluded by demonstrating an ankle-brachial index of more than 0.75. Exclusion criteria included active infection, ulcers of nonvenous etiology, current use of systemic corticosteroids, chemo- or radiotherapy, confinement to bed or chair, and active participation in another investigational study.

Treatment Protocol and Follow-up

The ulcers of the control subjects were dressed and bandaged using the Profore 4-layer bandage system (4-LB; Smith and Nephew, Largo Fla; Figure 1). In the IPC treatment group, the ulcers were dressed and bandaged using the same 4-layer bandage system described for the control group. In the IPC group, additional compression therapy was provided by a 4-chamber intermittent gradient, sequential, pneumatic compression device (Sequential Circulator Model 2004; BioCompression Inc, Moonachie, NJ; Figure 2). Therapy sessions were performed for 1 hour twice daily (morning and evening) at 40 to 50 mm Hg while the subject was in a reclining or decubitus position. Compression therapy with IPC was performed over the compression bandage. In all cases, either the 19- or 31-in leg sleeves were used. Daily diaries were maintained by the study subjects, and the IPC devices and sleeves were checked every 4 weeks. In-service to the patient and family was provided. All subjects were followed weekly for 96 weeks. At each weekly evaluation visit, the wounds were measured, wound and pain assessments were performed, and adverse events (if any) were recorded. For most patients, bandage changes were performed twice weekly (once at the Wound Center and once by the visiting nurse). Wound measurements were performed using a 3-megapixel digital camera and photo-digital planimetry software (Pictzar; CDM BioVisual Inc, Elmwood Park, NJ).

Figure 1.

Compression bandaging using the 4-layer bandage system.

Figure 2.

IPC therapy with intermittent, pneumatic, gradient, sequential compression pump and sleeves. IPC indicates intermittent pneumatic compression.

processing....