Effects of High Voltage Pulsed Current (HVPC) and Low Level Laser Therapy (LLLT) on Wound Healing in Diabetic Ulcers

NCT00719251 | Completed DMC

• 2 other identifiers: 1102-04-12916103-2003
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare the effects of high voltage pulsed current and low level laser therapy on the healing process of diabetic foot ulcers.

Conditions

Diabetic Foot Ulcer

Keywords

Complications of Diabetes Mellitus; Electric stimulation; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (5)

• Characteristics of the wound

  The wounds were evaluated at the beginning of the study (debridement previous), each two weeks during the intervention, at the finish of treatment and 30 and 60 days after completion of the intervention

• Ankle Brachial Index (ABI)

  The Ankle Braquial Index (ABI) was evaluated at the beginning of the study (debridement previous), each two weeks during the intervention, at the finish of treatment and 30 and 60 days after completion of the intervention.

• Sensory testing with the Semmes-Weinstein monofilament

  The monofilament testing was performed at the beginning and end of the treatment and 60 days thereafter.

• Neuroconduction studies with the Nicolet Compass Meridian equipment.

  The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.

• Quality of life with the EQ-5D.

  The quality of life was applied at the begining and at the end of the treatment.

Secondary Outcomes (1)

• Sociodemographic data like gender and age, were recorded. Additionally clinical history, deformities, alcohol dependence or smoking history, previous and present pharmacologic treatment and corticosteroids were included.

  These outcome measures were assessed in the initial examination.

Study Arms (3)

HVG

EXPERIMENTAL

The patients received standard nursing care and HVPC

Device: High voltage pulsed current

LG

EXPERIMENTAL

These patients received standard nursing care and LLLT

Device: Low level laser

CG

ACTIVE COMPARATOR

The control group only was treated with standard nursing care

Other: Standard nursing care

Interventions

High voltage pulsed current DEVICE

The patient´s wounds were treated for 45 minutes with HVPC three times a week for 16 weeks or until their ulcers closed. The active electrode made of aluminum foil was secured directly over the wound, which previously had been loosely packed with sterile gauze soaked with 0.9% saline solution. The dispersive electrode was placed 5 cms proximal to the wound.The electrical stimulator Intelect 340 stim model (Chattanooga Group) produces a twin peaked pulse and was applied with the following parameters: continuous mode, submotor level, 100 Hz pulse frequency and 100microseconds pulse duration. Prior to the beginning the study the electrical stimulator was calibrated with oscilloscope (Tektronix TDS 1002 model).

Also known as: -electric stimulation, -high voltage stimulation

HVG

Low level laser DEVICE

Wavelenght 633 nm (DMC - Brazil), power 30 mW, continuous, 2 J/cm2 in the edge of the ulcer and 1.5 J/cm2 in the bed, punctual application in direct contact, 3 times a week, 1 every alternate day, for 16 weeks or until the ulcer closed. The laser device was calibrated before each treatment session with a research radiometer (International Light).

Also known as: Soft laser, Laser therapy, LLLT

LG

Standard nursing care OTHER

It was based to nursing intervention classification (NIC)46. These interventions were performed by a qualified nurse and included ulcer irrigation with physiological saline, sharp debridement as needed and maintenance of a moist wound environment with appropriate wound dressing. Patients were all educated regarding pressure off loading of the involved foot. All patients received standard wound care seven times a week for 16 weeks or until their ulcers closed.

Also known as: Standard wound care, Wound care

CG

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 30 - 75 years
• Ulcer located on the legs or feet, stage I or II (Wagner Classification System)
• Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, two random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)

You may not qualify if:

• Uncontrolled diabetes
• Ulcer infection
• Lower limb amputation
• Orthopedic or neuromuscular pathologic conditions

Sponsors & Collaborators

• Universidad Industrial de Santander: lead

Study Sites (1)

Industrial University of Santander UIS

Bucaramanga, Santander Department, Colombia

Location

Related Publications (14)

• Goldman RJ, Brewley BI, Golden MA. Electrotherapy reoxygenates inframalleolar ischemic wounds on diabetic patients: a case series. Adv Skin Wound Care. 2002 May-Jun;15(3):112-20. doi: 10.1097/00129334-200205000-00006.

  PMID: 12055444 BACKGROUND

• Goldman R, Rosen M, Brewley B, Golden M. Electrotherapy promotes healing and microcirculation of infrapopliteal ischemic wounds: a prospective pilot study. Adv Skin Wound Care. 2004 Jul-Aug;17(6):284-94. doi: 10.1097/00129334-200407000-00010.

  PMID: 15289715 BACKGROUND

• Peters EJ, Lavery LA, Armstrong DG, Fleischli JG. Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial. Arch Phys Med Rehabil. 2001 Jun;82(6):721-5. doi: 10.1053/apmr.2001.23780.

  PMID: 11387573 BACKGROUND

• Houghton PE, Kincaid CB, Lovell M, Campbell KE, Keast DH, Woodbury MG, Harris KA. Effect of electrical stimulation on chronic leg ulcer size and appearance. Phys Ther. 2003 Jan;83(1):17-28.

  PMID: 12495409 BACKGROUND

• Hopkins JT, McLoda TA, Seegmiller JG, David Baxter G. Low-Level Laser Therapy Facilitates Superficial Wound Healing in Humans: A Triple-Blind, Sham-Controlled Study. J Athl Train. 2004 Sep;39(3):223-229.

  PMID: 15496990 BACKGROUND

• Schindl A, Schindl M, Schon H, Knobler R, Havelec L, Schindl L. Low-intensity laser irradiation improves skin circulation in patients with diabetic microangiopathy. Diabetes Care. 1998 Apr;21(4):580-4. doi: 10.2337/diacare.21.4.580.

  PMID: 9571346 BACKGROUND

• Demir H, Balay H, Kirnap M. A comparative study of the effects of electrical stimulation and laser treatment on experimental wound healing in rats. J Rehabil Res Dev. 2004 Mar;41(2):147-54. doi: 10.1682/jrrd.2004.02.0147.

  PMID: 15558369 BACKGROUND

• Reddy GK. Comparison of the photostimulatory effects of visible He-Ne and infrared Ga-As lasers on healing impaired diabetic rat wounds. Lasers Surg Med. 2003;33(5):344-51. doi: 10.1002/lsm.10227.

  PMID: 14677162 BACKGROUND

• Maiya GA, Kumar P, Rao L. Effect of low intensity helium-neon (He-Ne) laser irradiation on diabetic wound healing dynamics. Photomed Laser Surg. 2005 Apr;23(2):187-90. doi: 10.1089/pho.2005.23.187.

  PMID: 15910184 BACKGROUND

• Al-Watban FA, Zhang XY, Andres BL. Low-level laser therapy enhances wound healing in diabetic rats: a comparison of different lasers. Photomed Laser Surg. 2007 Apr;25(2):72-7. doi: 10.1089/pho.2006.1094.

  PMID: 17508840 BACKGROUND

• Zinman LH, Ngo M, Ng ET, Nwe KT, Gogov S, Bril V. Low-intensity laser therapy for painful symptoms of diabetic sensorimotor polyneuropathy: a controlled trial. Diabetes Care. 2004 Apr;27(4):921-4. doi: 10.2337/diacare.27.4.921.

  PMID: 15047649 BACKGROUND

• Corazza AV, Jorge J, Kurachi C, Bagnato VS. Photobiomodulation on the angiogenesis of skin wounds in rats using different light sources. Photomed Laser Surg. 2007 Apr;25(2):102-6. doi: 10.1089/pho.2006.2011.

  PMID: 17508845 BACKGROUND

• Silveira PC, Streck EL, Pinho RA. Evaluation of mitochondrial respiratory chain activity in wound healing by low-level laser therapy. J Photochem Photobiol B. 2007 Mar 1;86(3):279-82. doi: 10.1016/j.jphotobiol.2006.10.002. Epub 2006 Nov 20.

  PMID: 17113781 BACKGROUND

• Kawalec, JS. Pfennigwerth, TC. Hetherington, VJ. Logan, JS. A review of lasers in healing diabetic ulcers. The foot. 14:68-71, 2004.

  RESULT

Related Links

• American Diabetes Association home page
• Universidad Industrial de Santander - home page

MeSH Terms

Conditions

Diabetic Foot; Diabetes Complications

Interventions

Electric Stimulation; Low-Level Light Therapy; Laser Therapy

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Therapeutics; Phototherapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• MARIA CRISTINA SANDOVAL ORTIZ, MSc in P.T.

  Industrial University of Santander

  PRINCIPAL INVESTIGATOR

• ESPERANZA HERRERA VILLABONA, M.Sc. Phys

  Industrial University of Santander

  PRINCIPAL INVESTIGATOR

• DIANA MARINA CAMARGO LEMOS, M.Sc. Epid

  Industrial University of Santander

  STUDY CHAIR

• RAFAEL CASTELLANOS, Dr.

  Industrial Universtiy of Santander

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: March 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 5, 2009

Record last verified: 2009-03

Locations

CO (1)