To assess and compare the effects of a supervised structured exercise program on Wound Surface Area, Wound Depth, Ankle-Brachial Index, Blood Parameters (IL-6, IL-10, IGF-1, VEGF, TNF-α) and Quality of Life among type II diabetic patients with plantar ulcers and the control group
Design
Two arm parallel group randomized controlled trial with blinded outcome assessment on 46 patients. Randomization using 6x4 concealed blocks and Online Randomization software
Settings and conduct
Outcome assessor will be blinded to allocation both before and after the intervention
The study will be carried out in Tehran University of Medical Sciences Diabetes Center
Participants/Inclusion and exclusion criteria
Type 2 diabetic patients with plantar ulcer and without any extreme or life threatening complications such as immunodeficiency, heart failure or any other organ disease. Average diabetic foot patients who can benefit from supervised structured exercise.
Intervention groups
The interventional group receives standard care (daily wound dressing change) + 12 weeks (3 sessions/week) of supervised structured exercise (aerobic + resistance) and structured home based exercise in the other 3 days of the week.
Main outcome variables
Wound surface area, Wound depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201214049723N1
Registration date:2021-01-07, 1399/10/18
Registration timing:prospective
Last update:2021-01-07, 1399/10/18
Update count:1
Registration date
2021-01-07, 1399/10/18
Registrant information
Name
MohammadAli Shakoorianfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3783 1505
Email address
mashakoorianfard1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-24, 1400/01/04
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 12-week Aerobic and Lower Extremity Resistance Exercises on Healing of Plantar Ulcers in Type 2 Diabetic Patients
Public title
The Effect of 12-week Aerobic and Lower Extremity Resistance Exercises on Healing of Plantar Ulcers in Type 2 Diabetic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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 plantar ulcer that has not healed during the last 4 weeks despite receiving standard medical care
1 cm2 ≤ Wound Surface Area ≤ 16 cm2
The ulcer must be classified as grade 1 or 2, stage A or C under the UTCS
At least 18 years of age
BMI < 35
0.7 ≤ ABI ≤ 1.2
6.5% ≤ HbA1C ≤ 9.5%
100 ≤ FBS ≤ 250 mg/dl
Sedentary lifestyle for the last 6 months
Receiving at least 8 years of education within the IRI educational system
Exclusion criteria:
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
Macroalbuminuria
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
Dialysis
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
Missing 3 consecutive or 4 non-consecutive sessions during the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified block randomization using "wound grade" as matching factor between the groups. Online Randomization software will be used in randomization process. There will be 6 blocks, each containing 4 letters (e.g. AABB) as half of each block belongs to the control group and the other half belongs to the interventional group. These 6 blocks will be sorted out in a randomized fashion as well. The blocks will be placed in different sealed envelopes prepared by a third party that has no participation in any of the research stages whatsoever. Each time one of these envelopes will be unsealed randomly and 4 patients will be allocated according to the sequence of the letters inside that block. Then the envelope will be sealed and put in its position again.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor will be blind to allocation before and after the intervention period.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 41, 5th alley, Najafzadeh Ave., Basij Blvd.
City
Qom
Province
Ghoum
Postal code
3715966345
Approval date
2020-12-06, 1399/09/16
Ethics committee reference number
IR.IUMS.REC.1399.969
Health conditions studied
1
Description of health condition studied
Type 2 diabetic foot ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
Wound surface area, Wound depth
Timepoint
Baseline, at the end of 4th, 8th and 12th weeks
Method of measurement
Wound depth measurement probes for wound depth, Taking pictures and using the "NIH Imagej" software for wound surface area measurement
Secondary outcomes
1
Description
Quality of life
Timepoint
Baseline and the end of 12th week
Method of measurement
Iranian version of The Short Form 36 Health Survey (SF-36)
2
Description
Ankle Brachial Index (ABI)
Timepoint
Baseline, at the end of 4th, 8th and 12th weeks
Method of measurement
Ankle Brachial Index measurement device which measures systolic blood pressure at arm and ankle levels and calculates the exact value
Taking blood samples and using special laboratory kits
Intervention groups
1
Description
Control group: Wound washing using saline and wound dressing change as standard care
Category
Treatment - Other
2
Description
Intervention group: Wound washing using saline and wound dressing change as standard care + 12 weeks (3 sessions/week) of supervised aerobic and resistance exercise and home based range of motion exercise (3 days/week)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr. Saeedreza Mehrpour
Street address
Jalal-e-Al-e-Ahmad Hwy., Kargar Shomali St.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 1444
Fax
+98 21 8863 3039
Email
Shariati-Hospital-IPD@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas Motevallian
Street address
Shahid Hemmat Hwy.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
+98 21 8805 2248
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Ali Shakoorianfard
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 41, 5th alley, Najafzadeh Ave., Basij Blvd.
City
Qom
Province
Ghoum
Postal code
3715966345
Phone
+98 25 3783 1505
Email
mashakoorianfard1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Behnoosh Vasaghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of Basic Sciences in Rehabilitation, School of Rehabilitation Sciences, Madadkaran alley, Shahnazari Ave., Madar Sq., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
bvasaghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Ali Shakoorianfard
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 41, 5th alley, Najafzadeh Ave., Basij Blvd.
City
Qom
Province
Ghoum
Postal code
3715966345
Phone
+98 25 3783 1505
Email
mashakoorianfard1995@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Iran University of Medical Sciences will decide whether to publish the data or not.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available