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临床试验/IRCT20201214049723N1
IRCT20201214049723N1尚未招募未知

The Effect of 12-week Aerobic and Lower Extremity Resistance Exercises on Healing of Foot Ulcers in Type 2 Diabetic Patients

Iran University of Medical Sciences0 个研究点目标入组 26 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
入组人数
26

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 no limit(—)
性别
All

入选标准

  • Type II DM according to ADA criteria for less than 20 years
  • Receiving medical care (diet, oral agents, insulin) throughout the disease course
  • Stable hypoglycemic medications (type & dosage) within the last 2 months
  • Existence of at least one foot ulcer with Wound Surface Area = 16 cm2
  • The ulcer must be classified as grade 2, stage A or C under the UTCS
  • Stable anti inflammatory drugs (drugs prescribed to control HTN or hyperlipidemia) during the last 3 months
  • At least 18 years of age
  • 0.7 = ABI = 1.4
  • 6.5% = HbA1C = 9.5%
  • 100 = FBS = 250 mg/dl
  • Sedentary lifestyle for the last 6 months

排除标准

  • Cognitive or mental deficit
  • Wound treatments other than standard care (deemed to be required by the physician) such as growth factors, NPWT, hyperbaric oxygen, special dressings, etc.
  • Ulcer requiring surgical operations other than debridement
  • Non-diabetic ulcers such as electrical, chemical or radiation burns, etc.
  • Pregnancy or breast feeding
  • Infection or OM
  • Critical limb ischemia or lower extremity gangrene
  • Proliferative retinopathy or history of retinal detachment
  • Moderate or severe kidney disease
  • History of major lower extremity amputation
  • Severe liver disease
  • Uncontrolled HTN or BP higher than 160/95 mmHg
  • Life-threatening disease such as malignancy
  • History of DVT during the last 6 months
  • Active cellulitis or collagen vascular disease
  • Active Charcot
  • Present history of smoking or alcoholism
  • Immunodeficiency caused by immunosuppressant usage or chemotherapy during the past 2 months, radiotherapy within the last 4 months or systemic diseases
  • Presence of any overt cardiovascular condition diagnosed by cardiologist that prevents the patient from performing vigorous activities
  • Any kind of disease or condition (orthopedic, neurologic, pulmonary, arthritis, etc.) that limits or contraindicates physical activity
  • Presence of any condition considered as absolute contraindication for physical activity by the ACSM’s guideline
  • Participating in any experimental or non-experimental program that requires regular physical activity

研究者

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