Diabetes Mellitus Clinical Trial
Official title:
Effects of Phototherapy on the Healing of Ulcers Following Minor Lower Extermity Amputations in Patients With Diabetes Mellitus - Protocol for a Randomized, Controlled, Double-blind, Clinical Trial
Diabetes mellitus is a major public health problem and it is estimated that 300 million individuals will be affected by the year 2030. Non-diabetic ulcers are one of the most frequent complications of this disease and, if untreated, can lead to the amputation of lower limbs. Thus, there has been growing interest in the use of light emitting diode (LED) devices to accelerate the tissue repair process and lower the cost of ulcer treatment in this population. The Mandaqui hospital complex is a general, tertiary, teaching hospital that is a reference center for revascularization surgery and endovascular treatment in Brazil. The aim of the proposed study is to evaluate the action of LED therapy on the complete healing of ulcers following minor amputations in patients with Diabetes mellitus. Methods: A single-center, randomized, controlled, double-blind, clinical trial with two parallel groups will be conducted following the criteria of the CONSORT Statement. The project will be registered with www.clinicaltrials.gov. The sample will be composed of 40 patients with a diagnosis of Diabetes mellitus in follow up at the vascular clinic of Mandaqui hospital complex who meet the inclusion criteria. The control group (n = 20) will receive traditional rayon bandages with essential fatty acids and secondary coverage with gauze, which will be changed on a weekly basis. The treatment group (n = 20) will be submitted to LED therapy (635 nm; 4 J/cm2; 10 minutes) with weekly applications and the ulcers will also receive the traditional bandage treatment described above. The patients will be followed up until the complete closure of the ulcer, which will be the primary outcome. The ulcers will be examined on a weekly basis by a researcher with no awareness regarding the allocation of the individuals to the different groups and will assess, signs of infection, edema, redness, heat and the presence of gangrene. Photographs of the ulcers will also be taken for the subsequent determination of the area. Another researcher with no knowledge regarding the allocation of the participants will measure the surface of the ulcers with the aid of the ImageJ software program. The data will be submitted to appropriate statistical analyses. After closure of the ulcers, the patients will be followed up for a period of six months.
Justification Various studies have demonstrated that phototherapy (laser or LED) is effective
at enhancing skin wounds. The biological effects of both forms are similar and related to an
increase in fibroblasts, the stimulation of angiogenesis, an increase in collagen synthesis,
the formulation of granulation tissue and a reduction in inflammatory cells. Moreover, both
forms of phototherapy increase the healed area in a shorter period of time, with LED
demonstrating a late-onset effect on the healing process. In patients with partial foot
amputation, this time is crucial for the fitting of the prosthetic and, consequently, the
beginning of physical therapy and early locomotion. Diminishing the treatment time, with the
patient observing a gradual progression in the healing process and experiencing a consequent
increase in quality of life, could be a transforming factor to avoid the recurrence of ulcers
and avoid further amputations.
Hypothesis
Alternative hypothesis: LED therapy is effective at potentiating the complete closure of
ulcers in a shorter time following minor amputations in individuals with Diabetes mellitus.
Hull hypothesis: LED therapy is not effective at potentiating the complete closure of ulcers
in a shorter time following minor amputations in individuals with Diabetes mellitus.
Methods A single-center, randomized, controlled, double-blind clinical trial with two
parallel groups will be conducted in accordance with the criteria contained in the
Consolidated Standards of Reporting Trials (CONSORT statement).
The sample will be composed of patients diagnosed with Diabetes mellitus in medical follow up
at the vascular outpatient clinic of the Mandaqui Hospital Complex of São Paulo. Twenty
patients will be analyzed in each group, as this is the estimate of surgical treatment for
each vascular surgeon in a one-year period at the Mandaqui Hospital Complex.
Randomization and formation of groups Patient allocation will be performed by a researcher
with no contact with the patients or main researchers. Randomization will be conducted in
blocks of four for the balanced distribution of the experimental groups. For such, a lottery
of 40 numbers will be conducted using a free program available at
http://www.randomization.com, version from March 29, 2013.
Opaque envelopes will be identified with sequential numbers. A piece of paper containing
information on the corresponding group determined through the randomization process (control
or LED) will be placed into each envelope. The envelopes will remain sealed in numeric order
in a secure location until the time of the treatments of the post-amputation ulcers. The
researcher in charge of the randomization process and preparation of the envelopes will not
be involved in any other aspect of the study.
Immediately following surgery, the main researcher, who will be in the surgical ward, will
open an envelope without altering the numeric sequence and will perform the procedure
indicated (active LED + bandaging or placebo LED + bandaging). The 40 patients will be
allocated to the experimental and control groups in an equal fashion.
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