Determining the effect of local dextrose injection on pain, wound healing process and inflammatory markers in patients with diabetic foot ulcer
Design
Two arm parallel group block randomised trial with triple-blinded postoperative care and outcome assessment
Settings and conduct
The study will be conducted on patients with diabetes type 1 or 2, in Shariati hospital, Tehran for 1 year. Patients will be divided into 2 groups receiving dextrose 10%(intervention group) or normal saline(control group) 3 times per week for 1 month. The study is triple blinded and none of the patients, study investigators and data assessors know the type of treatment given to the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients older than 18 years
Patients with type 1 and 2 diabetes mellitus
HbA1C = 7-10%
Ability to understand and collaborate during the study
At least one chronic ulcer lasting for more than 4 weeks
Ulcer in plantar or dorsal surface of foot or in the malleolus
Ankle-brachial index = 0.7 - 1.2 in ischemic ulcers
Wagner grade 2, 3
Wound area 1-20 cm2
None of the patients had received glucocorticoid, estrogen or other drugs interfere healing process within the past 1 month
Intervention groups
The study will have 2 groups. One group will receive dextrose 10% as intervention group and the other will utilize injecting normal saline, as control group.
Comparing the effect of Prolotherapy with Placebo, in patients with diabetic foot ulcer
Public title
Studying the Effect of prolotherapy in diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 18 years old
Patients with confirmed type 1 or 2 diabetes mellitus
HbA1C = 7-10%
Ability to understand and collaborate during the study
Having at least one chronic ulcer lasting for more than 4 weeks
Plantar or dorsal or malleolar ulceration
ABI = 0.7 - 1.2 in ischemic ulcers
Ulcers with Wagner grades 2, 3
Ulcers with wound area = 1-20 cm2
None of the patients had received glucocorticoid, estrogen, or other drugs that interfere healing process within the past 1 month
Patients who signed the informed consent
Exclusion criteria:
Patients with a history of malignancy or coagulopathy
GFR < 30 ml/min/1.73m2
Albumin level < 3.5 g/dl
Pregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We used the block randomization method and our randomization unit was individual. Random blocks were chosen using the site www.sealedenvelope.com. Block sizes were 4, 6, and 8 and each block had both intervention A, and B equally.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Our study was designed triple blinded and none of the patient, study investigator and data analyzer knew the type of intervention given to the patient. The drug will be provided by someone not involved in the study so the executors will be blind about the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences