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Clinical Application of a Portable Sequential Compressive Boot: Reduction of Edema and Prevention of VLUs. Paul Kesselman, DPM, FACFAS Brooklyn, New York References: Chen, A.H., Frangos, S.G., Kilaru, S., Sumpio, B.E. (2001). Intermittent pneumatic compression devices-physiological mechanisms of action. European Journal Vascular and Endovascular Surgery, 21, 383-392. Valencia, I.C., Falabella, A., Kirsner, R.S., Eaglstein, W.H. (2001). Chronic venous insufficiency and venous leg ulceration. Journal of American Academy Dermatology, 44(3): 401-421. Vowden, K. (2001). The use of mobile intermittent pneumatic compression in venous ulceration. British Journal of Nursing, 10 (8): 491-500. INTRODUCTION Chronic venous insufficiency often leads to edema, pain, venous leg ulcers (VLU) and significant interference with the performance of activities of daily living (ADLs). Patient compliance with the use of compression stockings or standard electrical sequential pumps is often difficult because of physical difficulties and discomfort in application or use, and interference with ADLs. This is due to the fact that currently available pumps are not designed to be portable, thus necessitating application in the home, rendering patients immobile for several hours per day. Insurance coverage for these devices is difficult to achieve, particularly when VLUs are no longer present. PURPOSE The purpose of this investigation was to trial a new, fully sequential and gradient mobile intermittent pneumatic compression (MIPC) device* for a patient with edema and a recurrent VLU refractory to treatment. The mobile intermittent pneumatic compression device allows for complete patient mobility and was recently cleared by the FDA. The device offers the user a choice: to receive therapy without the need for electrical connection or to receive therapy while connected to a small mini-compressor while at rest. It is significantly less expensive than standard sequential compressive devices. CLINICAL PRESENTATION A 76 year-old non-diabetic male, with a contra-lateral drop foot secondary to a cerebral vascular accident, suffered from venous stasis for approximately 10 years while under the care of this investigator. When he was younger he was able to wear compression stockings. However, due to advancing age related maladies (e.g. reduced flexibility and vision), he has been unable to consistently use compression stockings. Despite periodic leg elevation and application of topical steroid creams, his venous stasis and stasis dermatitis has progressively worsened. Recent trauma on the lower extremities resulted in a venous ulcerations which were refractive to closure. Due to his religious beliefs, compliance with an electric powered boot would be difficult (if not impossible) to achieve. The MIPC device offered the patient the freedom of using the device while ambulating and during his holy days, or using the device powered by electricity while at work. RESULTS The patient was easily educated by the clinician regarding product use. He used the device while at work and during periods of ambulation. He reported that the device was easy to apply and remove. Rapid resolution of venous stasis and healing of the ulcers site was noted. This was accompanied by reduction in pain, edema, and leg fatigue. Calf and ankle measurements verified edema reduction. MIPC allowed the patient to be compliant with his treatment regimen at work when sedentary while powered to a mini-compressor. Additionally, it afforded him the opportunity to use the non-electrical component while ambulatory and during times when he was unable to use electrical powered devices. METHODS: The patient agreed to trial the MIPC device. He had a long history of conservative therapy (ie., appropriate compression bandages, stockings, wound dressings, exercise, and elevation of the limb). The wounds failed to heal. Advancing age with associated reduction in flexibility and vision contributed to his inability to comply with prescribed compression. As a result he continued to experience pain, edema, and non-healing venous ulcerations. The physician completed an order form which included demographic information, patient assessment data, insurance information (primary and secondary) and a Certificate of Medical Necessity. Coverage was verified by a durable medical equipment provider. The patient was instructed to use the self-powered sequential compression device whenever he was walking. While at work and resting he was instructed to connect the electrical mini-compressor for at least two 1-hour sessions per day. Outcomes data was collected for the patient’s report of comfort, ease of application and removal of the device, edema, and ability to utilize the device as prescribed. Calf and ankle measurements were recorded prior to initiating the device and several weeks later. CONCLUSION Use of an intermittent pneumatic sequential compression device with a “self-powered” pump was able to prevent and/or reduce edema in this patient while he was walking or standing. His venous ulcers healed and he was able to enjoy his usual activities of daily living while wearing the MIPC device. Further studies are indicated. AFTER: The MIPC was connected to power 3-4 hours daily. The device was worn without connection to power most of the day and all day on Fridays, Saturdays, and holidays. After two weeks of therapy the edema was rapidly reduced and the right leg ulcer is healed. The calf region measured 13.5 inches and the ankle measured 10 inches after two weeks of therapy. LEFT LEG RIGHT LEG AFTER: Two weeks after using the MIPC device bilaterally, the ulcer on the left leg is resolved. Edema is controlled. BEFORE: The ulcerated area on the left leg was at high risk of reopening. The patient is unable to consistently apply compression hose due to advancing age related maladies. Use of an electric powered compression device was not an option for a variety of reasons. The MIPC device was prescribed. BEFORE: 76 year-old male with venous stasis who sustained trauma resulting in ulceration. Use of standard compression stockings were too difficult for him to apply. Despite periodic leg elevation and application of topical steroid creams, his venous stasis and stasis dermatitis progressively worsened. The ulcerated area on the right leg was at high risk of reopening. The calf region measured 15.5 inches and the ankle measured 11 inches prior to start of therapy. *MOBILITY 1™, Mobile intermittent Pneumatic Compression Device, Derma Sciences, Inc., Princeton, New Jersey. Funding for costs associated with this poster provided by Derma Sciences, Inc.

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Page 1: medihoney poster

Clinical Application of a Portable Sequential Compressive Boot: Reduction of Edema and Prevention of VLUs.

Paul Kesselman, DPM, FACFASBrooklyn, New York

References:

Chen, A.H., Frangos, S.G., Kilaru, S., Sumpio, B.E. (2001). Intermittent pneumatic compression devices-physiological mechanisms of action. European Journal Vascular and Endovascular Surgery, 21, 383-392.Valencia, I.C., Falabella, A., Kirsner, R.S., Eaglstein, W.H. (2001). Chronic venous insufficiency and venous leg ulceration. Journal of American Academy Dermatology, 44(3): 401-421.Vowden, K. (2001). The use of mobile intermittent pneumatic compression in venous ulceration. British Journal of Nursing, 10(8): 491-500.

INTRODUCTION

Chronic venous insufficiency often leads to edema, pain, venous leg ulcers (VLU) and significant interference with the performance of activities of daily living (ADLs). Patient compliance with the use of compression stockings or standard electrical sequential pumps is often difficult because of physical difficulties and discomfort in application or use, and interference with ADLs. This is due to the fact that currently available pumps are not designed to be portable, thus necessitating application in the home, rendering patients immobile for several hours per day. Insurance coverage for these devices is difficult to achieve, particularly when VLUs are no longer present.

PURPOSE

The purpose of this investigation was to trial a new, fully sequential and gradient mobile intermittent pneumatic compression (MIPC) device* for a patient with edema and a recurrent VLU refractory to treatment.

The mobile intermittent pneumatic compression device allows for complete patient mobility and was recently cleared by the FDA. The device offers the user a choice: to receive therapy without the need for electrical connection or to receive therapy while connected to a small mini-compressor while at rest. It is significantly less expensive than standard sequential compressive devices.

CLINICAL PRESENTATIONA 76 year-old non-diabetic male, with a contra-lateral drop foot secondary to a cerebral vascular accident, suffered from venous stasis for approximately 10 years while under the care of this investigator. When he was younger he was able to wear compression stockings. However, due to advancing age related maladies (e.g. reduced flexibility and vision), he has been unable to consistently use compression stockings. Despite periodic leg elevation and application of topical steroid creams, his venous stasis and stasis dermatitis has progressively worsened. Recent trauma on the lower extremities resulted in a venous ulcerations which were refractive to closure.

Due to his religious beliefs, compliance with an electric powered boot would be difficult (if not impossible) to achieve. The MIPC device offered the patient the freedom of using the device while ambulating and during his holy days, or using the device powered by electricity while at work.

RESULTS

The patient was easily educated by the clinician regarding product use. He used the device while at work and during periods of ambulation. He reported that the device was easy to apply and remove. Rapid resolution of venous stasis and healing of the ulcers site was noted. This was accompanied by reduction in pain, edema, and leg fatigue. Calf and ankle measurements verified edema reduction.

MIPC allowed the patient to be compliant with his treatment regimen at work when sedentary while powered to a mini-compressor. Additionally, it afforded him the opportunity to use the non-electrical component while ambulatory and during times when he was unable to use electrical powered devices.

METHODS:The patient agreed to trial the MIPC device. He had a long history of conservative therapy (ie., appropriate compression bandages, stockings, wound dressings, exercise, and elevation of the limb). The wounds failed to heal. Advancing age with associated reduction in flexibility and vision contributed to his inability to comply with prescribed compression. As a result he continued to experience pain, edema, and non-healing venous ulcerations.

The physician completed an order form which included demographic information, patient assessment data, insurance information (primary and secondary) and a Certificate of Medical Necessity. Coverage was verified by a durable medical equipment provider.

The patient was instructed to use the self-powered sequential compression device whenever he was walking. While at work and resting he wasinstructed to connect the electrical mini-compressor for at least two 1-hour sessions per day.

Outcomes data was collected for the patient’s report of comfort, ease of application and removal of the device, edema, and ability to utilize the device as prescribed. Calf and ankle measurements were recorded prior to initiating the device and several weeks later.

CONCLUSIONUse of an intermittent pneumatic sequential compression device with a “self-powered” pump was able to prevent and/or reduce edema in this patient while he was walking or standing. His venous ulcers healed and he was able to enjoy his usual activities of daily living while wearing the MIPC device. Further studies are indicated.

AFTER: The MIPC was connected to power 3-4 hours daily. The device was worn without connection to power most of the day and all day on Fridays, Saturdays, and holidays.After two weeks of therapy the edema was rapidly reduced and the right leg ulcer is healed. The calf region measured 13.5 inches and the ankle measured 10 inches aftertwo weeks of therapy.

LEFT LEG

RIGHT LEG

AFTER: Two weeks after using the MIPC device bilaterally, the ulcer on the left leg is resolved. Edema is controlled.

BEFORE: The ulcerated area on the left leg was at high risk of reopening. The patient is unable to consistently apply compression hose due to advancing age related maladies. Use of an electric powered compression device was not an option for a variety of reasons. The MIPC device was prescribed.

BEFORE: 76 year-old male with venous stasis who sustained trauma resulting in ulceration. Use of standard compression stockings were too difficult for him to apply. Despite periodic leg elevation and application of topical steroid creams, his venous stasis and stasis dermatitis progressively worsened. The ulcerated area on the right leg was at high risk of reopening. The calf region measured 15.5 inches and the ankle measured 11 inches prior to start of therapy.

*MOBILITY 1™, Mobile intermittent Pneumatic Compression Device, Derma Sciences, Inc., Princeton, New Jersey. Funding for costs associated with this poster provided by Derma Sciences, Inc.