Diabetic Foot UlcersNCT02785198
Passive Training as a Treatment for Diabetic Foot Ulcers
A study testing Passive knee extensor machine in people with Diabetic Foot Ulcers, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Overall project design: This PhD project involves a randomized study on diabetic individuals with healing resistant wounds, comparing the effect of passive movement of the lower limb with standard treatment of diabetic wounds. How to effectively improve the condition of peripheral arterial disease is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Passive knee extensor machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2016to Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Diabetes mellitus according to the World Health Organisation (WHO) criteria (see http://www.who.int/diabetes/publications/en/ ) and a stable treatment treated in a period of 14 days prior to screening with insulin or an oral antidiabetic agent. Stable is defined as stable HBA1c.
- 4. Foot ulcer: size: diameter > 1cm. Duration of wound > 6 weeks Location: Full thickness skin defect distal to the malleoli.
- 5. Male or female, age >18 years at the time of signing informed consent. 6. Non-dementia diagnosis.
Who cannot join
- Major infection; acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity.
- Malignant disease
- Major traumatic tissue damage.
- Major lower extremity amputation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passive Training as a Treatment for Diabetic Foot Ulcers: A Randomized, Single-blinded Clinical Trial of Wound Healing
Overall project design: This PhD project involves a randomized study on diabetic individuals with healing resistant wounds, comparing the effect of passive movement of the lower limb with standard treatment of diabetic wounds.
How to effectively improve the condition of peripheral arterial disease is limited. The primary purpose of this study is to uncover whether passive movement of the lower limb will influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle oxygen demand is likely to increase both blood flow rate and the number of capillaries, which would induce the healing of wounds, that were not previously possible.
Read more
The secondary purpose is to increase understanding of the pathophysiological processes in wound healing through the study of biochemical markers of vascularization, inflammation and stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of the number and quality of endothelial cells and Capillary density and to develop new quantifiable methods to evaluate wound healing in.
The project is a randomized trial, consisting of simple passive training to improve blood vessel function, increase the growth of the smallest blood vessels, thereby preventing ulceration and ultimately amputation.
Read the detailed description
Background information
Diabetic foot ulcers are one of the most frequent and serious complication in diabetes mellitus. Despite attempts of prophylaxis*, only two-thirds of the diabetic foot ulcers eventually heal, and up to 15-20% will ultimately require a minor or major amputation (Major lower extremity amputation is defined as through or above the ankle joint, and minor amputations is below the ankle joint. The incidence of diabetes is growing, but the multifactorial causes of impaired healing of chronic diabetic ulcers are still not well understood.
The diabetic foot ulcers are known to reduce the quality of life for patients both psychically and psychologically and therefore further investigation in new treatment options is plausible. Current knowledge regarding how to improve the condition in the beginning phase of peripheral artery disease (PAD) is limited. Investigators know that high oxygen tension and perfusion of the limb as well as an adequate density of microvessels in the tissue, is essential to wound healing. Therefore, interventions that increase blood flow and promote microcirculatory growth are likely to be beneficial in the treatment of wound healing.
*Dressings, debridement, compression, clinical observation, antibiotics and glycemic control
It has been reported that passive training consisting of knee flexion/extension in a kinetic machine has a beneficial effect on up regulation of growth factors, remicrovascularization and improved blood flow. Høier et al described that passive movement of the leg induced a two-fold elevation in blood flow, elevation of angiogenic factors and initiates capillarization in skeletal muscle. All three factors are often impaired in the diabetic leg, which results in poor wound healing.
Due to the typical localization of the diabetic foot ulcers, this patient group is unable to exercise properly. Therefore will the investigators use a recent innovative model for the improvement of the limb microcirculation, developed at the Department of Nutrition, Exercise and Sports, University of Copenhagen, involving passive movement of the lower leg, for inducing increased blood flow and microcirculatory growth.
Rationale for the trial Diabetic patients have impaired wound healing due to multifactorial causes. The investigators know that high oxygen tension, and perfusion is essential to wound healing, and according to Høier et al's study, passive training can increase the perfusion and elevate proangiogenic factors in both young healthy males and peripheral artery disease (PAD) patients.
Null hypothesis:
- Passive training does not lead to enhanced healing of diabetic foot ulcers.
- Passive training of the lower limb does not affect perfusion of the trained limb.
Perspective:
This projects aim is to discover that passive training of the lower limb will increase the healing in diabetic foot ulcers. In addition, present a new treatment offer to diabetic patients with ulcers, who are not able to heal properly or perform active exercises. The investigators hope to see that the benefits of training and accelerated healing affect the PROM's.
Further on to present new knowledge of the specific molecular and functional changes that occur in the tissue during wound healing. This knowledge will be very important to improve our understanding of why ulcerations occur and why the tissue begins to decompose.
This is a prospective, randomized, single-blinded, parallel controlled design trial in subjects with diabetes mellitus investigating passive training as a treatment for the diabetic ulcer. The participants are randomized to either a control group or intervention.
The control group receiving standard wound treatment, and an intervention group receiving standard wound treatment, and passive training exercises for 8 weeks. The participants will be followed for 16 weeks or until clinical wound healing. All participants will receive standard wound care consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics The comparison groups should be as similar as possible as regard to important participant characteristics that might influence the response to the intervention. Therefore, a block randomization to ensure that equal numbers of participants with a characteristic thought to affect prognosis or response to the intervention, will be allocated to each comparison group.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Passive knee extensor machine
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive knee extensor machineDevice
The passive training machine, moves both legs from flexion to extension and back, 60 times per minute in 1 hour, 3 times per week. ROM is 60 degrees
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | A control group receiving standard wound treatment consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics. |
| Passive training group | Experimental | An Intervention group doing passive exercise for 8 weeks in knee extensor machine, and receiving standard wound treatment consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics. Receives: Device: Passive knee extensor machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing change quantified by digital photo planimetry
The digital photo planimetry measurements are compared to the baseline measurement at week 0
Measured: Photos are taken at week 0 and 8
The change in Wagner's wound classification.
measurements at baseline are compared to week 8
Measured: week 0 and 8
The change in Wagner's wound classification.
The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8
Measured: week 3, 5 and 16
Wound healing change quantified by digital photo planimetry
The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8
Measured: week 3, 5 and 16
Secondary outcomes (31)
Perfusion of the lower extremity.
Quantified by measuring the blood flow in arteria femoralis (doppler)
Measured: week 0, 3, 5, 8 and 16.
Distal blood pressure measurement.
Includes skin perfusion test
Measured: week 0 and 8.
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Hemoglobin mmol/L
Measured: Week 0, 5 and 8
Histological changes of the muscle tissue.
Analysed from muscle biopsies
Measured: Week 0,5 and 8
Histological changes of the tissue composition in the edge of the wound.
Analysed from wound edge biopsy
Measured: Week 0,5 and 8
Angiogenetic factors analysed from muscle biopsy
- Total RNA isolated from the muscle biopsies, and the mRNA content of VEGF, eNOS, MMP-2, MMP-9, TIMP-1, TIMP-2, Tie-2, ANG-1, ANG-2 determined by PCR
Measured: Week 0,5 and 8
Dexa Scanning of the lower limb.
To measure the tissue composition change
Measured: Week 0 and 8
Dexa Scanning of the lower limb.
To measure the bone mineral density change
Measured: Week 0 and 8
Patient related outcome measurements (PROM's)
Medical Outcome Study Short Form 36 (MOS SF36)
Measured: Week 0, 8 and 16
the change in 30 second chair stand test
Measured: Week 0 and 8
the change in maximum leg extension test
Measured: Week 0 and 8
Adverse events
Measured: Week 0, 3, 5, 8 and 16
Autonomic neuropathy
vagus device measurements at baseline and after 8 weeks
Measured: Week 0 and 8
Distal blood pressure change measurement.
Arm, ankle and toe pressure. The ankle brachial index (ABI) is calculated from measuring the arm and ankle systolic blood pressure.
Measured: week 0 and 8
Autonomic neuropathy
sudoscan measurements at baseline and after 8 weeks
Measured: Week 0 and 8
Patient related outcome measurements (PROM's)
the Euroqol five Dimensions questionnaire (EQ-5D)
Measured: Week 0, 8 and 16
Histological changes of the endothelial cells
analysed from muscle biopsies
Measured: 0,5 and 8
Histological changes of the capillary density
Analysed from muscle biopsies
Measured: 0,5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Glycated HbA1c in mmol/mol
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Glucose in mmol/l
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
C-reactive protein in mg/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
leucocytes and differential count, in 10^9/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Thrombocytes in 10^9/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Sodium,mmol/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
potassium in mmol/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
eGlomerular filtration rate, mL/min/1,73 m^2
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Albumin g/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Creatinine, μmol/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Alanine Transaminase, U/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Basic Phosphatase, U/L
Measured: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
YKL 40, μg/L
Measured: Week 0, 5 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2018
- Study completionJul 2018
Why it stopped: due to finalizing af phd project and fundings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Tue Smith Jørgensen, Herlev Hospital
- Investigators
- Tue Smith Joergensen, MD, Principal investigator, Herlev and Gentofte Hospital, The Department of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785198
- Sponsor's protocol ID
- H-15008102
- Status last verified
- Feb 2020
- First submitted
- 13 May 2016
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt PJ. Lower extremity amputations--a review of global variability in incidence. Diabet Med. 2011 Oct;28(10):1144-53. doi: 10.1111/j.1464-5491.2011.03279.x.
PubMed 21388445Tennvall GR, Apelqvist J, Eneroth M. Costs of deep foot infections in patients with diabetes mellitus. Pharmacoeconomics. 2000 Sep;18(3):225-38. doi: 10.2165/00019053-200018030-00003.
PubMed 11147390Baltzis D, Eleftheriadou I, Veves A. Pathogenesis and treatment of impaired wound healing in diabetes mellitus: new insights. Adv Ther. 2014 Aug;31(8):817-36. doi: 10.1007/s12325-014-0140-x. Epub 2014 Jul 29.
PubMed 25069580Hinchliffe RJ, Valk GD, Apelqvist J, Armstrong DG, Bakker K, Game FL, Hartemann-Heurtier A, Londahl M, Price PE, van Houtum WH, Jeffcoate WJ. A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S119-44. doi: 10.1002/dmrr.825.
PubMed 18442185Gary Sibbald R, Woo KY. The biology of chronic foot ulcers in persons with diabetes. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S25-30. doi: 10.1002/dmrr.847.
PubMed 18442179Jorgensen ME, Almdal TP, Faerch K. Reduced incidence of lower-extremity amputations in a Danish diabetes population from 2000 to 2011. Diabet Med. 2014 Apr;31(4):443-7. doi: 10.1111/dme.12320. Epub 2013 Oct 21.
PubMed 24111834Vogel TR, Petroski GF, Kruse RL. Impact of amputation level and comorbidities on functional status of nursing home residents after lower extremity amputation. J Vasc Surg. 2014 May;59(5):1323-30.e1. doi: 10.1016/j.jvs.2013.11.076. Epub 2014 Jan 7.
PubMed 24406089McDonald S, Sharpe L, Blaszczynski A. The psychosocial impact associated with diabetes-related amputation. Diabet Med. 2014 Nov;31(11):1424-30. doi: 10.1111/dme.12474. Epub 2014 May 24.
PubMed 24766143Jeffcoate WJ, Harding KG. Diabetic foot ulcers. Lancet. 2003 May 3;361(9368):1545-51. doi: 10.1016/S0140-6736(03)13169-8.
PubMed 12737879Pence BD, Woods JA. Exercise, Obesity, and Cutaneous Wound Healing: Evidence from Rodent and Human Studies. Adv Wound Care (New Rochelle). 2014 Jan 1;3(1):71-79. doi: 10.1089/wound.2012.0377.
PubMed 24761347Rasmussen BSB, Yderstraede KB, Carstensen B, Skov O, Beck-Nielsen H. Substantial reduction in the number of amputations among patients with diabetes: a cohort study over 16 years. Diabetologia. 2016 Jan;59(1):121-129. doi: 10.1007/s00125-015-3781-7. Epub 2015 Nov 22.
PubMed 26590707Hellsten Y, Rufener N, Nielsen JJ, Hoier B, Krustrup P, Bangsbo J. Passive leg movement enhances interstitial VEGF protein, endothelial cell proliferation, and eNOS mRNA content in human skeletal muscle. Am J Physiol Regul Integr Comp Physiol. 2008 Mar;294(3):R975-82. doi: 10.1152/ajpregu.00677.2007. Epub 2007 Dec 19.
PubMed 18094062Hoier B, Rufener N, Bojsen-Moller J, Bangsbo J, Hellsten Y. The effect of passive movement training on angiogenic factors and capillary growth in human skeletal muscle. J Physiol. 2010 Oct 1;588(Pt 19):3833-45. doi: 10.1113/jphysiol.2010.190439.
PubMed 20693292
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Training as a Treatment for Diabetic Foot Ulcers: A Randomized, Single-blinded Clinical Trial of Wound Healing
- ClinicalTrials.gov ID
- NCT02785198
- Acronym / sponsor ID
- H-15008102
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to finalizing af phd project and fundings
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 27 May 2016 (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.
Overall project design: This PhD project involves a randomized study on diabetic individuals with healing resistant wounds, comparing the effect of passive movement of the lower limb with standard treatment of diabetic wounds.
How to effectively improve the condition of peripheral arterial disease is limited. The primary purpose of this study is to uncover whether passive movement of the lower limb will influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle oxygen demand is likely to increase both blood flow rate and the number of capillaries, which would induce the healing of wounds, that were not previously possible.
The secondary purpose is to increase understanding of the pathophysiological processes in wound healing through the study of biochemical markers of vascularization, inflammation and stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of the number and quality of endothelial cells and Capillary density and to develop new quantifiable methods to evaluate wound healing in.
The project is a randomized trial, consisting of simple passive training to improve blood vessel function, increase the growth of the smallest blood vessels, thereby preventing ulceration and ultimately amputation.
Detailed description
Background information
Diabetic foot ulcers are one of the most frequent and serious complication in diabetes mellitus. Despite attempts of prophylaxis*, only two-thirds of the diabetic foot ulcers eventually heal, and up to 15-20% will ultimately require a minor or major amputation (Major lower extremity amputation is defined as through or above the ankle joint, and minor amputations is below the ankle joint. The incidence of diabetes is growing, but the multifactorial causes of impaired healing of chronic diabetic ulcers are still not well understood.
The diabetic foot ulcers are known to reduce the quality of life for patients both psychically and psychologically and therefore further investigation in new treatment options is plausible. Current knowledge regarding how to improve the condition in the beginning phase of peripheral artery disease (PAD) is limited. Investigators know that high oxygen tension and perfusion of the limb as well as an adequate density of microvessels in the tissue, is essential to wound healing. Therefore, interventions that increase blood flow and promote microcirculatory growth are likely to be beneficial in the treatment of wound healing.
*Dressings, debridement, compression, clinical observation, antibiotics and glycemic control
It has been reported that passive training consisting of knee flexion/extension in a kinetic machine has a beneficial effect on up regulation of growth factors, remicrovascularization and improved blood flow. Høier et al described that passive movement of the leg induced a two-fold elevation in blood flow, elevation of angiogenic factors and initiates capillarization in skeletal muscle. All three factors are often impaired in the diabetic leg, which results in poor wound healing.
Due to the typical localization of the diabetic foot ulcers, this patient group is unable to exercise properly. Therefore will the investigators use a recent innovative model for the improvement of the limb microcirculation, developed at the Department of Nutrition, Exercise and Sports, University of Copenhagen, involving passive movement of the lower leg, for inducing increased blood flow and microcirculatory growth.
Rationale for the trial Diabetic patients have impaired wound healing due to multifactorial causes. The investigators know that high oxygen tension, and perfusion is essential to wound healing, and according to Høier et al's study, passive training can increase the perfusion and elevate proangiogenic factors in both young healthy males and peripheral artery disease (PAD) patients.
Null hypothesis:
- Passive training does not lead to enhanced healing of diabetic foot ulcers.
- Passive training of the lower limb does not affect perfusion of the trained limb.
Perspective:
This projects aim is to discover that passive training of the lower limb will increase the healing in diabetic foot ulcers. In addition, present a new treatment offer to diabetic patients with ulcers, who are not able to heal properly or perform active exercises. The investigators hope to see that the benefits of training and accelerated healing affect the PROM's.
Further on to present new knowledge of the specific molecular and functional changes that occur in the tissue during wound healing. This knowledge will be very important to improve our understanding of why ulcerations occur and why the tissue begins to decompose.
This is a prospective, randomized, single-blinded, parallel controlled design trial in subjects with diabetes mellitus investigating passive training as a treatment for the diabetic ulcer. The participants are randomized to either a control group or intervention.
The control group receiving standard wound treatment, and an intervention group receiving standard wound treatment, and passive training exercises for 8 weeks. The participants will be followed for 16 weeks or until clinical wound healing. All participants will receive standard wound care consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics The comparison groups should be as similar as possible as regard to important participant characteristics that might influence the response to the intervention. Therefore, a block randomization to ensure that equal numbers of participants with a characteristic thought to affect prognosis or response to the intervention, will be allocated to each comparison group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –A control group receiving standard wound treatment consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics. |
| Passive training group | Experimental | Device: Passive knee extensor machineAn Intervention group doing passive exercise for 8 weeks in knee extensor machine, and receiving standard wound treatment consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Diabetes mellitus according to the World Health Organisation (WHO) criteria (see http://www.who.int/diabetes/publications/en/ ) and a stable treatment treated in a period of 14 days prior to screening with insulin or an oral antidiabetic agent. Stable is defined as stable HBA1c.
- 4. Foot ulcer: size: diameter > 1cm. Duration of wound > 6 weeks Location: Full thickness skin defect distal to the malleoli.
- 5. Male or female, age >18 years at the time of signing informed consent. 6. Non-dementia diagnosis.
Key exclusion criteria (4 listed)
- Major infection; acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity.
- Malignant disease
- Major traumatic tissue damage.
- Major lower extremity amputation.
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 |
|---|---|---|
| Passive knee extensor machineThe passive training machine, moves both legs from flexion to extension and back, 60 times per minute in 1 hour, 3 times per week. ROM is 60 degrees | Device | Passive training group |
Primary outcome
Wound healing change quantified by digital photo planimetry
Time frame: Photos are taken at week 0 and 8
The digital photo planimetry measurements are compared to the baseline measurement at week 0
The change in Wagner's wound classification.
Time frame: week 0 and 8
measurements at baseline are compared to week 8
The change in Wagner's wound classification.
Time frame: week 3, 5 and 16
The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8
Wound healing change quantified by digital photo planimetry
Time frame: week 3, 5 and 16
The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8
31 secondary outcomes
Perfusion of the lower extremity.
Time frame: week 0, 3, 5, 8 and 16.
Distal blood pressure measurement.
Time frame: week 0 and 8.
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
Histological changes of the muscle tissue.
Time frame: Week 0,5 and 8
Histological changes of the tissue composition in the edge of the wound.
Time frame: Week 0,5 and 8
Angiogenetic factors analysed from muscle biopsy
Time frame: Week 0,5 and 8
Dexa Scanning of the lower limb.
Time frame: Week 0 and 8
Dexa Scanning of the lower limb.
Time frame: Week 0 and 8
Patient related outcome measurements (PROM's)
Time frame: Week 0, 8 and 16
the change in 30 second chair stand test
Time frame: Week 0 and 8
the change in maximum leg extension test
Time frame: Week 0 and 8
Adverse events
Time frame: Week 0, 3, 5, 8 and 16
Autonomic neuropathy
Time frame: Week 0 and 8
Distal blood pressure change measurement.
Time frame: week 0 and 8
Autonomic neuropathy
Time frame: Week 0 and 8
Patient related outcome measurements (PROM's)
Time frame: Week 0, 8 and 16
Histological changes of the endothelial cells
Time frame: 0,5 and 8
Histological changes of the capillary density
Time frame: 0,5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples.
Time frame: Week 0, 5 and 8
Results and safety
The study was stopped early (reason given: due to finalizing af phd project and fundings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Background: PubMed 21388445Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt PJ. Lower extremity amputations--a review of global variability in incidence. Diabet Med. 2011 Oct;28(10):1144-53. doi: 10.1111/j.1464-5491.2011.03279.x.
- Background: PubMed 11147390Tennvall GR, Apelqvist J, Eneroth M. Costs of deep foot infections in patients with diabetes mellitus. Pharmacoeconomics. 2000 Sep;18(3):225-38. doi: 10.2165/00019053-200018030-00003.
- Background: PubMed 25069580Baltzis D, Eleftheriadou I, Veves A. Pathogenesis and treatment of impaired wound healing in diabetes mellitus: new insights. Adv Ther. 2014 Aug;31(8):817-36. doi: 10.1007/s12325-014-0140-x. Epub 2014 Jul 29.
- Background: PubMed 18442185Hinchliffe RJ, Valk GD, Apelqvist J, Armstrong DG, Bakker K, Game FL, Hartemann-Heurtier A, Londahl M, Price PE, van Houtum WH, Jeffcoate WJ. A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S119-44. doi: 10.1002/dmrr.825.
- Background: PubMed 18442179Gary Sibbald R, Woo KY. The biology of chronic foot ulcers in persons with diabetes. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S25-30. doi: 10.1002/dmrr.847.
- Background: PubMed 24111834Jorgensen ME, Almdal TP, Faerch K. Reduced incidence of lower-extremity amputations in a Danish diabetes population from 2000 to 2011. Diabet Med. 2014 Apr;31(4):443-7. doi: 10.1111/dme.12320. Epub 2013 Oct 21.
- Background: PubMed 24406089Vogel TR, Petroski GF, Kruse RL. Impact of amputation level and comorbidities on functional status of nursing home residents after lower extremity amputation. J Vasc Surg. 2014 May;59(5):1323-30.e1. doi: 10.1016/j.jvs.2013.11.076. Epub 2014 Jan 7.
- Background: PubMed 24766143McDonald S, Sharpe L, Blaszczynski A. The psychosocial impact associated with diabetes-related amputation. Diabet Med. 2014 Nov;31(11):1424-30. doi: 10.1111/dme.12474. Epub 2014 May 24.
- Background: PubMed 12737879Jeffcoate WJ, Harding KG. Diabetic foot ulcers. Lancet. 2003 May 3;361(9368):1545-51. doi: 10.1016/S0140-6736(03)13169-8.
- Background: PubMed 24761347Pence BD, Woods JA. Exercise, Obesity, and Cutaneous Wound Healing: Evidence from Rodent and Human Studies. Adv Wound Care (New Rochelle). 2014 Jan 1;3(1):71-79. doi: 10.1089/wound.2012.0377.
- Background: PubMed 26590707Rasmussen BSB, Yderstraede KB, Carstensen B, Skov O, Beck-Nielsen H. Substantial reduction in the number of amputations among patients with diabetes: a cohort study over 16 years. Diabetologia. 2016 Jan;59(1):121-129. doi: 10.1007/s00125-015-3781-7. Epub 2015 Nov 22.
- Background: PubMed 18094062Hellsten Y, Rufener N, Nielsen JJ, Hoier B, Krustrup P, Bangsbo J. Passive leg movement enhances interstitial VEGF protein, endothelial cell proliferation, and eNOS mRNA content in human skeletal muscle. Am J Physiol Regul Integr Comp Physiol. 2008 Mar;294(3):R975-82. doi: 10.1152/ajpregu.00677.2007. Epub 2007 Dec 19.
- Individual participant dataSharing planned: No
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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.
Tue Smith Joergensen, MD principal investigator
Herlev and Gentofte Hospital, The Department of Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive knee extensor machine in people with Diabetic Foot Ulcers, run by Herlev Hospital at 1 site in Denmark.
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 4 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: stopped early, as of the sponsor's last update on 24 Feb 2020. 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 Denmark. 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 was stopped early (reason given: due to finalizing af phd project and fundings). Results are not available in the source record.
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?
Wound healing change quantified by digital photo planimetry (time frame: Photos are taken at week 0 and 8). The study lists 4 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 NCT02785198, which also lists 13 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 24 Feb 2020.