Protocol summary
-
Study aim
-
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 foot ulcers and the control group
-
Design
-
Two arm parallel group randomized controlled trial with blinded outcome assessment on 26 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 No.1
-
Participants/Inclusion and exclusion criteria
-
Type 2 diabetic patients with foot 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
General information
-
Reason for update
-
The temporary shutdown of university treatment centers and the lack of access to the patients due to COVID-19 pandemic, forced the research team to postpone the initiation of sampling and research process so far. In the meantime, some new research results and articles were obtained by the research team that based on which, the sample size and design of the current research needs some editing. It is important to mention that the sampling process has not begun yet.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20201214049723N1
Registration date:
2021-01-07, 1399/10/18
Registration timing:
prospective
Last update:
2021-06-09, 1400/03/19
Update count:
1
-
Registration date
-
2021-01-07, 1399/10/18
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-06-22, 1400/04/01
-
Expected recruitment end date
-
2022-01-20, 1400/10/30
-
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 Foot Ulcers in Type 2 Diabetic Patients
-
Public title
-
The Effect of 12-week Aerobic and Lower Extremity Resistance Exercises on Healing of Foot 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 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
BMI < 35
0.7 ≤ ABI ≤ 1.4
6.5% ≤ HbA1C ≤ 9.5%
100 ≤ FBS ≤ 250 mg/dl
Sedentary lifestyle for the last 6 months
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
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
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
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
26
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Stratified block randomization using "dressing type" 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
-
Ethics committees
1
-
Ethics committee
-
-
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
-
Timepoint
-
Baseline, at the end of 4th, 8th and 12th weeks
-
Method of measurement
-
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
3
-
Description
-
5 blood parameters (Interleukin-6, Interleukin-10, Insulin-like Growth Factor-1, Tumor Necrosis Factor-α and Vascular Endothelial Growth Factor)
-
Timepoint
-
Baseline and at the end of 12th week
-
Method of measurement
-
Taking blood samples and using special laboratory kits
4
-
Description
-
Wound depth
-
Timepoint
-
Baseline, at the end of 4th, 8th and 12th weeks
-
Method of measurement
-
Using wound depth measurement sterile probe and disposable paper ruler
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
1
-
Sponsor
-
-
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
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