Diabetic FootNCT01499472
Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers
A study testing shock wave therapy and dermagold shockwave in people with Diabetic Foot, run by Hadassah Medical Organization.
Trial summary
The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- shock wave therapy and dermagold shockwave
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent.
- Diagnosed with Diabetes.
- An Active Diabetic Ulcer larger than 5 cm2
- Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)>=0.5
Who cannot join
- Pregnancy.
- The patient is under another research protocol.
- One of the following:
- ABI<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.
- The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
- Sufficient Noncompliant.
- Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids
About this study
Official title: ESWT Treatment of Diabetic Foot VS. Standard Care Trial
The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.
- Conditions
- Diabetic Foot
- Being tested
- shock wave therapy, dermagold shockwave, standard of care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock wave therapyDevice
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
dermagold shockwaveDevice
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
standard of careProcedure or surgery
regular care including debridement and bandaging.
| Study group | Role | What they receive |
|---|---|---|
| shock wave therapy, shortened wound healing time | Active comparator | Not described Receives: Device: shock wave therapy; Device: dermagold shockwave |
| normal wound care | Other | standard of care intervention Receives: Procedure: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
healed ulcer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ofer Elishuv, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499472
- Sponsor's protocol ID
- ofer02-HMO-CTIL
- Status last verified
- Aug 2011
- First submitted
- 4 Sep 2011
- Last updated
- 26 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESWT Treatment of Diabetic Foot VS. Standard Care Trial
- ClinicalTrials.gov ID
- NCT01499472
- Acronym / sponsor ID
- ofer02-HMO-CTIL
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 26 Dec 2011 (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 is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shock wave therapy, shortened wound healing time | Active comparator | Device: shock wave therapy, Device: dermagold shockwave |
| normal wound care | Other | Procedure: standard of carestandard of care intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed Informed Consent.
- Diagnosed with Diabetes.
- An Active Diabetic Ulcer larger than 5 cm2
- Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)>=0.5
Key exclusion criteria (7 listed)
- Pregnancy.
- The patient is under another research protocol.
- One of the following:
- The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
- Sufficient Noncompliant.
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 |
|---|---|---|
| shock wave therapyshock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments. | Device | shock wave therapy, shortened wound healing time |
| dermagold shockwaveshock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments. | Device | shock wave therapy, shortened wound healing time |
| standard of careregular care including debridement and bandaging. | Procedure or surgery | normal wound care |
Primary outcome
healed ulcer
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2011.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing shock wave therapy and dermagold shockwave in people with Diabetic Foot, run by Hadassah Medical Organization.
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 7 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: status not confirmed, as of the sponsor's last update on 26 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
healed ulcer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2011.