Those patients that will be treated by NPWT.

Those patients will be treated with standard saline moist wound care and dressing.

Diabetic Foot Ulcer

VAC was applied by placing sterile pads in two layers with a 16Fr Ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. The tube was connected to a wall-mounted suction device and the pressure will be set at −125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs

Negative Pressure Wound Therapy

Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.

Abdelrahman Ibrahim Sayed

Vascular Surgery Department, Assiut University

Assiut University

Routine rehabilitation program patient education

Routine rehabilitation program + foot exercise training

Diabetes Mellitus, Type 2

Peripheral Neuropathy

Patient education
All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS), hand-held dynamometer, range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test, circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment.

In addition to the patient education , foot exercise training will be performed. Patients will be applied exercise training consisted of aerobic, strengthening, sensory training and stretching exercises for 3 days/week, 8 weeks.
All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) ,hand-held dynamometer,range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test,circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment.

Istanbul University

Effectiveness of Foot Exercise People With Type 2 Diabetes

Effectiveness of Foot Exercise Training on Patients With Type 2 Diabetes and Peripheral Neuropathy

An instrument for determining sensitivity to pain produced by pressure.

The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale evaluates sensory dysfunction and whether the pain is caused by neuropathic mechanisms or not. The LANSS comprises a 5-item questionnaire regarding pain symptoms and two items for clinical signs involving self-administered sensory tests for the presence of allodynia and decreased sensation to pinprick. Responses to each item are binary (yes or no) and each item is weighted differently depending on the odds ratio of a positive response to each item to predict that the pain is primarily neuropathic. The possible scores range from 0 to 24, with a score of 12 or greater considered to be suggestive of neuropathic pain

Participants are asked to mark the point where they feel their pain on a 10 centimeter (cm) horizontal line. 0-no pain, 10-unbearable pain. Night, activity and pain conditions are evaluated separately at rest.

The Hand-Held Dynamometer (formerly known as the Manual Muscle Tester) is an ergonomic hand-held device for objectively quantifying muscle strength.

A goniometer is a device used in physical therapy to measure the range of motion around a joint in the body.

Baseline Tactile Semmes-Weinstein Monofilaments are designed to measure cutaneous sensory perception threshold of a patient.

Use a measuring tape to measure the circumference of your leg. Write down its circumference and repeat daily for a few days, using the same area on your the leg.

The 6-minute walk test is one of the functional exercise capacity assessment tests. In this test, participants are asked to walk as long as possible within 6 minutes in a 30 meter (m) corridor. When they feel fatigue or pain, they are advised to stop and rest when they feel ready to walk. At the end of 6 minutes, the total distance of the patients walking is recorded. Heart rates, systolic and diastolic blood pressures, O2 saturation, perceived fatigue and dyspnea levels are recorded before and after the test.

The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.

The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments.

HbA1c (A1c or glycosylated hemoglobin) is widely used as the most important marker for routine monitoring of long term glycemic status in patients with diabetes.

The kidneys are responsible for keeping the level of creatinine in the blood within a normal range. The typical reference range for serum creatinine is 60 to 110 micromoles per liter (μmol/L) (0.7 to 1.2 milligrams per deciliter (mg/dL)) for men and 45 to 90 μmol/L (0.5 to 1.0 mg/dL) for women.

A normal albumin range is 3.4 to 5.4 g/dL. If you have a lower albumin level, you may have malnutrition. It can also mean that you have liver disease or an inflammatory disease. Higher albumin levels may be caused by acute infections, burns, and stress from surgery or a heart attack.

Evrim KOÇARSLAN

physiotherapist

Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day.

Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day.
Avex Footbeat: Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion.

Avex Footbeat

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Balance will be quantified by measuring body sway in medial-lateral direction using a validated wearable sensors technology (Balansens, Biosensics LLC) and body sway change after 4-weeks of daily use of AVEX Footbeat will be assessed compare to baseline. Th unit of measurement is cm.

Change in Balance From Baseline to 4 Weeks

Skin perfusion was quantified using Skin Perfusion Pressure Test (SPP) at the lower extremities at baseline and at 4-week (end point). The measurement of SPP was done using a device called Sensilase PAD-IQ (VASAMED). The unit of measurement is mmHg.

Change in Skin Perfusion From Baseline to 4 Weeks

Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm.

Change in Lower Extremity Edema From Baseline to 4 Weeks

The change in plantar sensation after 4-weeks use of AVEX Footbeat will be assessed using vibratory perception threshold (VPT) test. The unit of this measurement is volt.

Change in Plantar Sensation From Baseline to 4-week

The change in stride velocity was quantified by gait speed measured using a validated wearable sensor (LEGSys, Biosensics, LLC). The unit of measurement is meter per second (m/s)

Change in Stride Velocity From Baseline to 4-week

Overall Study

Prof.

Diabetes

Lower Extremity Edema

Neuropathy;Peripheral

Foot Ulcer, Diabetic

Lymphatic Diseases

Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion.

Baylor College of Medicine

Micro-mobile Foot Compression and Diabetic Foot

Micro-mobile Foot Compression Device to Improve Motor-function in People With Diabetes and Loss of Protective Sensation

Only de-identified data and associated results will be published in peer-review papers or scientific abstracts. The de-identified data from changes in primary and secondary outcomes (e.g. changes in balance, gait, physical activity, edema, etc) may be shared upon approval of the sponsor.

Bijan Najafi, PhD

Professor of Surgery

Avex LLC

Eligible subjects will try a new offloading boot for 4 weeks

Offloading

A new offloading boot, which may enhance balance, gait, and lower extremity blood flow

Offloading boot : PulseFlow

Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study

skin perfusion measured in the ankle using Sensilase device

the quality of walking while wearing Pulseflow offflaoding compared to standard offloading

body sway measured while wearing Pulseflow offflaoding compared to standard offloading

assessing spontaneous daily physical activities using a special non-invasive sensor with accelerometers

adherence to wear offloading boot by downloading from the study device to a specific developed software.

Measuring Pain with VA Pain Questionnaire

Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts

The Diabetic Boot Company

Osteomyelitis

UT Southwestern Medical Center

Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis (PCT)

Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis

Serial measurements of procalcitonin at Baseline, Week 3 and Week 6.

University of Texas Southwestern Medical Center

Standard of Care will be utilized without the device.

The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.

Active

Standard of Care

Total

Race/Ethnicity, Customized

Active Device
The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.

Active Provant Device

The Incidence of Wounds Reaching Complete Closure

standardized care will be used for wound care on patients randomized to this arm.

VP of Clinical Research and Regulatory

Diabetic Foot Ulcers

The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.

The Provant Therapy System

Winston - Salem Outpatient Clinic

A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers

A Controlled Study Comparing Basic Wound Care to the Provant® Therapy System as an Adjunct to Basic Wound Care for Wound Surface Area Reduction in Diabetic Plantar Foot Wounds