Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-7563224-B2
Publication Date
2009-07-21
Expiration Date
Abstract
The present invention is directed to a specialized method of treating a severe diabetic ulcer that penetrates the subcutaneous fat layer of a patient. The method comprises the steps of: administering a treatment session to a diabetic patient having a severe diabetic ulcer, the treatment session comprising at least three pulsed electromagnetic fields (PEMF) applications, PEMF applications 1, 2, and 3, and at least two intermittent compression therapy (ICT) applications. The PEMF application and ICT therapy settings address specific factors that are necessary to induce healing of the diabetic ulcer and prevent amputation. In a preferred embodiment, the treatment session further comprises the step of applying a dressing having a silver and/or honey anti-infection composition thereon to the ulcer area to impede microbial growth in the ulcer area. In another embodiment, the method includes the step of applying ultrasound to the ulcer area for a time sufficient to inhibit microbial growth.
Core Innovation
The invention relates to a method of treating a severe diabetic ulcer that penetrates the subcutaneous fat layer in a diabetic patient. The problem being solved is the treatment of severe diabetic ulcers with ischemia, including management intended to prevent amputation. The method uses a treatment session administered at least once a day, and the session is directed to the ulcer area.
The treatment session comprises at least three pulsed electromagnetic field (PEMF) applications and at least two intermittent compression therapy (ICT) applications. The PEMF applications include PEMF applications 1, 2, and 3, each applied to the ulcer area for at least 10 minutes, with application-specific applicator power output and pulse parameters defined for each PEMF application.
The ICT applications include at least one venous therapy and at least one arterial therapy or venous/arterial therapy. The ICT is applied to the patient to increase blood flow and/or reduce vascular congestion to the severe diabetic ulcer area, with defined applied pressure ranges for venous therapy, arterial therapy, and venous/arterial therapy, and with the treatment session administered at least once a day or at least twice a day depending on the method. In some embodiments, an anti-infection dressing having a silver and/or honey anti-infection composition is applied on the ulcer area in an amount sufficient to impede microbial growth in the ulcer area.
Claims Coverage
The independent claims cover methods of treating a severe diabetic ulcer that penetrates the subcutaneous fat layer using combinations of PEMF applications and ICT applications, with quantitative PEMF pulse parameters and ICT pressure ranges. Across the independent claims, the inventive features involve combined multi-PEMF plus ICT session structure, quantified PEMF and ICT dosing-like parameters and session frequency, and optional addition of a silver and/or honey anti-infection dressing to impede microbial growth.
Sequential multi-PEMF and ICT treatment session
Administering a treatment session to a diabetic patient having a severe diabetic ulcer that penetrates the subcutaneous fat layer, wherein the treatment session comprises at least three pulsed electromagnetic fields (PEMF) applications (PEMF applications 1, 2, and 3) and at least two intermittent compression therapy (ICT) applications.
PEMF application-specific pulse parameters
Applying each of PEMF applications 1, 2, and 3 to the ulcer area for at least 10 minutes each, with application-specific applicator power output and pulse rate and pulse width ranges recited for each PEMF application.
ICT venous and arterial pressure ranges for ulcer-area perfusion
Applying the ICT applications to increase blood flow and/or reduce vascular congestion to the severe diabetic ulcer area, wherein the venous therapy has an applied pressure range, the arterial therapy has an applied pressure range, and the venous/arterial therapy has applied pressure ranges.
At-least-once daily session for severe diabetic ulcer treatment
Applying the treatment session to the patient at least once a day to treat the severe diabetic ulcer.
Silver and/or honey anti-infection dressing with PEMF plus ICT
Administering a treatment session comprising applying to the ulcer area a dressing having a silver and/or honey anti-infection composition thereon in an amount sufficient to impede microbial growth in the ulcer area, together with at least three PEMF applications and at least two ICT applications.
At-least-twice daily session with rest interval
Applying the treatment session to the patient at least twice a day with at least 7 to 10 hours of rest between treatment sessions to treat the severe diabetic ulcer.
The independent claims consistently require a combined treatment session for severe diabetic ulcers that penetrate the subcutaneous fat layer, using at least three distinct PEMF applications together with at least two ICT applications aimed at increasing blood flow and/or reducing vascular congestion. The claims further specify quantitative PEMF pulse parameters and quantitative ICT applied pressure ranges, with session frequency and rest intervals defined in one independent claim. One independent claim additionally requires a dressing having a silver and/or honey anti-infection composition applied in an amount sufficient to impede microbial growth in the ulcer area.
Stated Advantages
Increase blood flow to the severe diabetic ulcer area.
Reduce vascular congestion to the severe diabetic ulcer area.
Impeded microbial growth in the ulcer area.
Documented Applications
Treatment of a severe diabetic ulcer that penetrates the subcutaneous fat layer in a diabetic patient, including treatment sessions for severe diabetic ulcers with ischemia.
Amputation prevention.
Interested in licensing this patent?