Diabetic Foot UlcerNCT00719251
Effects of High Voltage Pulsed Current (HVPC) and Low Level Laser Therapy (LLLT) on Wound Healing in Diabetic Ulcers
A study testing High voltage pulsed current, Low level laser and Standard nursing care in people with Diabetic Foot Ulcer, run by Universidad Industrial de Santander at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- High voltage pulsed current, Low level laser and Standard nursing care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Uncontrolled diabetes
- Ulcer infection
- Lower limb amputation
- Orthopedic or neuromuscular pathologic conditions
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Industrial University of Santander UIS
Bucaramanga, Santander Department
About this study
Official title: Effects of High Voltage Pulsed Current and Low Level Laser Therapy on Wound Healing in Diabetic Ulcers.
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.
Read the detailed description
Based in the literature review we concluded that LLLT and HVPC are effective in the healing wound. We did not meet outcomes of previous clinical studies, where compare the effectivity of two physical technologies. For the high prevalence of diabetic foot ulcers, the amputation risk and the consequent impairment and dysfunction in the quality of life, and the associated high costs for this health problem, it is important that new studies that identified effective treatment alternatives for promoting wound closure.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- High voltage pulsed current, Low level laser, Standard nursing care
- Keywords
- Complications of Diabetes Mellitus, Electric stimulation, Low-Level Laser Therapy
- Medical subject headings
- Diabetic Foot, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High voltage pulsed currentDevice
Also called -electric stimulation, -high voltage stimulation
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).
Low level laserDevice
Also called Soft laser, Laser therapy, LLLT
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).
Standard nursing careOther
Also called Standard wound care, Wound care
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.
| Study group | Role | What they receive |
|---|---|---|
| HVG | Experimental | The patients received standard nursing care and HVPC Receives: Device: High voltage pulsed current |
| LG | Experimental | These patients received standard nursing care and LLLT Receives: Device: Low level laser |
| CG | Active comparator | The control group only was treated with standard nursing care Receives: Other: Standard nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of the wound
Measured: 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)
Measured: 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
Measured: 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.
Measured: The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.
Quality of life with the EQ-5D.
Measured: 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.
Measured: These outcome measures were assessed in the initial examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startMar 2004
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Industrial de Santander
- Sponsor type
- University, hospital or other
- Investigators
- MARIA CRISTINA SANDOVAL ORTIZ, MSc in P.T., Principal investigator, Industrial University of SantanderESPERANZA HERRERA VILLABONA, M.Sc. Phys, Principal investigator, Industrial University of SantanderDIANA MARINA CAMARGO LEMOS, M.Sc. Epid, Study chair, Industrial University of SantanderRAFAEL CASTELLANOS, Dr., Study chair, Industrial Universtiy of Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719251
- Sponsor's protocol ID
- 1102-04-12916
- Other IDs
- 103-2003
- Status last verified
- Mar 2009
- First submitted
- 18 Jul 2008
- Last updated
- 5 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12055444Goldman 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.
PubMed 15289715Peters 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.
PubMed 11387573Houghton 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.
PubMed 12495409Hopkins 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.
PubMed 15496990Schindl 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.
PubMed 9571346Demir 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.
PubMed 15558369Reddy 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.
PubMed 14677162Maiya 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.
PubMed 15910184Al-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.
PubMed 17508840Zinman 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.
PubMed 15047649Corazza 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.
PubMed 17508845Silveira 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.
PubMed 17113781Kawalec, JS. Pfennigwerth, TC. Hetherington, VJ. Logan, JS. A review of lasers in healing diabetic ulcers. The foot. 14:68-71, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Voltage Pulsed Current and Low Level Laser Therapy on Wound Healing in Diabetic Ulcers.
- ClinicalTrials.gov ID
- NCT00719251
- Acronym / sponsor ID
- 1102-04-12916
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Complications of Diabetes Mellitus, Electric stimulation, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Industrial de SantanderUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Based in the literature review we concluded that LLLT and HVPC are effective in the healing wound. We did not meet outcomes of previous clinical studies, where compare the effectivity of two physical technologies. For the high prevalence of diabetic foot ulcers, the amputation risk and the consequent impairment and dysfunction in the quality of life, and the associated high costs for this health problem, it is important that new studies that identified effective treatment alternatives for promoting wound closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HVG | Experimental | Device: High voltage pulsed currentThe patients received standard nursing care and HVPC |
| LG | Experimental | Device: Low level laserThese patients received standard nursing care and LLLT |
| CG | Active comparator | Other: Standard nursing careThe control group only was treated with standard nursing care |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Uncontrolled diabetes
- Ulcer infection
- Lower limb amputation
- Orthopedic or neuromuscular pathologic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High voltage pulsed currentAlso: -electric stimulation, -high voltage stimulationThe 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). | Device | HVG |
| Low level laserAlso: Soft laser, Laser therapy, LLLTWavelenght 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). | Device | LG |
| Standard nursing careAlso: Standard wound care, Wound careIt 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. | Other | CG |
Primary outcome
Characteristics of the wound
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.
Quality of life with the EQ-5D.
Time frame: The quality of life was applied at the begining and at the end of the treatment.
1 secondary outcome
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.
Time frame: These outcome measures were assessed in the initial examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2009.
- Background: PubMed 12055444Goldman 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.
- Background: PubMed 15289715Goldman 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.
- Background: PubMed 11387573Peters 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.
- Background: PubMed 12495409Houghton 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.
- Background: PubMed 15496990Hopkins 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.
- Background: PubMed 9571346Schindl 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.
- Background: PubMed 15558369Demir 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.
- Background: PubMed 14677162Reddy 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.
- Background: PubMed 15910184Maiya 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.
- Background: PubMed 17508840Al-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.
- Background: PubMed 15047649Zinman 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.
- Background: PubMed 17508845Corazza 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.
- American Diabetes Association home pageLink provided by the sponsor.
- Universidad Industrial de Santander - home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIA CRISTINA SANDOVAL ORTIZ, MSc in P.T. principal investigator
Industrial University of Santander
ESPERANZA HERRERA VILLABONA, M.Sc. Phys principal investigator
Industrial University of Santander
DIANA MARINA CAMARGO LEMOS, M.Sc. Epid study chair
Industrial University of Santander
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High voltage pulsed current, Low level laser and Standard nursing care in people with Diabetic Foot Ulcer, run by Universidad Industrial de Santander at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of the wound (time frame: 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719251, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2009.