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Phototherapy in DM Amputation Ulcers.

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ClinicalTrials.gov Identifier: NCT02883751
Recruitment Status : Unknown
Verified August 2016 by Cristiane Miranda Franca, University of Nove de Julho.
Recruitment status was:  Not yet recruiting
First Posted : August 30, 2016
Last Update Posted : August 31, 2016
Sponsor:
Collaborators:
Daniela de Fátima Teixeira da Silva
Monica Ribeiro Ventura
Information provided by (Responsible Party):
Cristiane Miranda Franca, University of Nove de Julho

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Amputation Stumps Diabetic Foot Radiation: LED Procedure: Control group Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Control group
Control group - gold standard: Conventional ulcer treatment with Rayon® and essential fatty acids (Dersani®). Cleaning of the surgical wound will be performed with saline solution. The wound will then be covered with a sterile polyethylene film, over which the LED plate will be positioned for placebo treatment (emission of sound, but with the device switched off). After 10 minutes, the LED plate and polyethylene film will be removed and the surgical wound will be covered with rayon moistened with essential fatty acids (following the standard protocol of the hospital), followed by the application of gauze and finalization with a crepe bandage.
Procedure: Control group
Conventional ulcer treatment with rayon® (Polar Fix, Polar Fix, Mauá, SP, Brazil) and essential fatty acids (Dersani®, Saniplan, Daudt, São Paulo, SP, Brazil) (composition: decanoic acid, caprylic acid, hexanoic acid, lauric acid, linoleic acid, lecithin, retinyl palmitate, tocopheryl acetate and alpha-tocopheryl).

Experimental: LED group
LED group: Cleaning of the surgical wound will be performed with saline solution and the wound will be covered with a sterile polyethylene film, over which the LED plate will be positioned for active treatment with the device switched on. After 10 minutes, the LED plate and polyethylene film will be removed and the surgical wound will be covered with rayon moistened with essential fatty acids (following the standard protocol of the hospital), followed by the application of gauze and finalization with a crepe bandage.
Radiation: LED
A device with 36, rectangular, red LEDs, registered with the Brazilian National Health Surveillance Agency (ANVISA authorization nº 8.04554.6), λ = (650 ± 20) nm, with an output power of 324 mW and an output area of 2.54 cm2 (Cosmedical, Brazil), will be enveloped with sterile, disposable, plastic wrap (transparent in the red wavelength) to permit contact with the skin for ten minutes during each session. The plastic wrap will be changed after each use. The amount of energy delivered will be 194.4 J.
Other Name: Photobiomodulation with light emmiting diode (LED)




Primary Outcome Measures :
  1. Wound closure [ Time Frame: 6 months ]
    The primary outcome will be the complete closure of the ulcer, which is defined as 100% epithelialization of the operated surface with no exudate, draining or need for bandages.


Secondary Outcome Measures :
  1. Time for closure [ Time Frame: up to 6 months ]
    time (in days) needed for complete ulcer closure.

  2. Ulcer closure rate [ Time Frame: up to 6 months ]
    On a weekly basis, the surgical wounds will be photographed with a digital camera (Canon Powershot S5 IS semi-professional, manual mode) on the upper and lower portions of the foot always at the same distance and with a millimeter scale on the left side for reading by the software program. The area of the ulcers will subsequently be measured with the aid of the ImageJ program (free software, NIH, Maryland, USA) and a software program developed by the research group for this purpose (Deana et al., 2013).

  3. Cost-benefit ratio of ulcer treatment following minor amputations [ Time Frame: up to 6 months ]
    The cost-benefit analysis will involve the determination of expenditures on materials, equipment, labor and transportation costs calculated as a function of treatment time.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years or older;
  • type 2 diabetes;
  • either gender;
  • adequate cognitive capacity to maintain the foot without load or pressure as much as possible based on the location of the ulcer;
  • under care at the vascular surgery outpatient clinic of the Mandaqui Hospital Complex between January 2017 and december 2018, having undergone partial minor amputation at the same hospital (toes, foot, disarticulation at the metatarsal-phalangeal or transmetatarsal joint).

Exclusion Criteria:

  • presence of infected ulcers;
  • under surveillance for cancer or having undergone anti-neoplasm treatment in previous three months;
  • currently pregnant or nursing;
  • uncontrolled diabetes;
  • Neuropathic arthropathy;
  • participation in other concomitant clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883751


Contacts
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Contact: Daniela Teixeira da Silva, PhD 551133859222 fatesi@uol.com.br
Contact: Monica R Ventura, MD 5511993497943 venturamr63@gmail.com

Locations
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Brazil
Universidade Nove de Julho
São Paulo, SP, Brazil, 01504015
Sponsors and Collaborators
University of Nove de Julho
Daniela de Fátima Teixeira da Silva
Monica Ribeiro Ventura
Investigators
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Principal Investigator: Cristiane M Franca, PhD University of Nove de Julho

Publications of Results:
Other Publications:
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Responsible Party: Cristiane Miranda Franca, Professor at the Biophotonics applied to Health Sciences Post Graduation Program, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02883751     History of Changes
Other Study ID Numbers: 1.464.664
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cristiane Miranda Franca, University of Nove de Julho:
diabetes mellitus
amputation stumps
diabetic foot
phototherapy
clinical trial
Additional relevant MeSH terms:
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Diabetic Foot
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies