Chronic Diabetic Foot UlcersSTUFNCT00954343
Shockwave Treatment of Diabetic Foot Ulcer: Step I
A study testing Extracorporeal Shock Wave in people with Chronic Diabetic Foot Ulcers, run by Technical University of Munich at 1 site in Germany.
Trial summary
Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diabetic Foot Ulcers
- What is being tested?
- Extracorporeal Shock Wave
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to not given
- 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
- Age 18 and older
- Diabetes Type I or II
- Chronic ulcer on the foot
- Ulcer present for at least 6 weeks
- Wagner Grade 1 or 2
Who cannot join
- Chronic rest pain
- Critical ischemia
- Gangrene
- Ankle-Arm-Index < 0,5
- Critical ischemia treated within 6 weeks before possible enrollment
- Ulcer of Grade 3 or worse according to the Wagner Classification
Show all 25Show fewer
- Osteomyelitis
- Affection of toes
- Necessity of surgical intervention
- Malalignment of the foot sustaining the ulcer
- Treatment of Ulcer with Prostaglandins or vasodilatators within the last 2 weeks
- Current therapy with corticoids
- Infection with HIV; Hepatitis
- Suppression of immune system (due to illness or medication)
- Medication with Vitamin-K-Antagonists
- Known hemophilia
- Sever Hypalbuminemia < 2 g/dl
- Severe anemia
- Ulcer other than of diabetic origin
- Pregnant or breast-feeding women
- Known coagulopathies
- Implants such as artificial heart valves, joint replacement, bone replacement, osteosynthesis material
- Patients participating on other studies
- Chemotherapy within the last 60 days
- Mentally disabled patients
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar
Munich, Bavaria, 81675
About this study
Official title: Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1
Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. It has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.
In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.
Read more
The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). One group serves as an untreated control group. All groups get standardized wound treatment and wound dressing.
That shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (RCT).
- Conditions
- Chronic Diabetic Foot Ulcers
- Being tested
- Extracorporeal Shock Wave
- Keywords
- Foot Ulcers, Extracorporeal Shockwave, Chronic wound
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock WaveProcedure or surgery
Extracorporeal Shock WaveProcedure or surgery
Extracorporeal Shock WaveProcedure or surgery
Extracorporeal Shock WaveProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Not described Receives: Procedure: Extracorporeal Shock Wave |
| Group II | Experimental | Not described Receives: Procedure: Extracorporeal Shock Wave |
| Group III | Experimental | Not described Receives: Procedure: Extracorporeal Shock Wave |
| Group IV | Experimental | Not described Receives: Procedure: Extracorporeal Shock Wave |
| Group V | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage decrease of ulcer size twelve weeks after treatment begin (i.e. first shock wave treatment) compared to the baseline (ulcer size at first treatment)
Secondary outcomes (3)
Rate of completely healed ulcer 6, 9 and 12 weeks after first treatment
Percentage decrease of ulcer size 6 and 9 weeks after first treatment
Tissue oxygen concentration after shock wave treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcersStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Hans Gollwitzer, PD Dr., CCRP, Principal investigator, Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954343
- Sponsor's protocol ID
- 2456/09
- Acronym
- STUF
- Status last verified
- Mar 2013
- First submitted
- 31 Jul 2009
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1
- ClinicalTrials.gov ID
- NCT00954343
- Acronym / sponsor ID
- STUF / 2456/09
- Conditions
- Chronic Diabetic Foot Ulcers
- Keywords
- Foot Ulcers, Extracorporeal Shockwave, Chronic wound
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2009
- First posted
- 7 Aug 2009 (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.
Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. It has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.
In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.
The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). One group serves as an untreated control group. All groups get standardized wound treatment and wound dressing.
That shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Extracorporeal Shock Wave |
| Group II | Experimental | Procedure: Extracorporeal Shock Wave |
| Group III | Experimental | Procedure: Extracorporeal Shock Wave |
| Group IV | Experimental | Procedure: Extracorporeal Shock Wave |
| Group V | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and older
- Diabetes Type I or II
- Chronic ulcer on the foot
- Ulcer present for at least 6 weeks
- Wagner Grade 1 or 2
Key exclusion criteria (25 listed)
- Chronic rest pain
- Critical ischemia
- Gangrene
- Ankle-Arm-Index < 0,5
- Critical ischemia treated within 6 weeks before possible enrollment
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 |
|---|---|---|
| Extracorporeal Shock Wave | Procedure or surgery | Group I |
| Extracorporeal Shock Wave | Procedure or surgery | Group II |
| Extracorporeal Shock Wave | Procedure or surgery | Group III |
| Extracorporeal Shock Wave | Procedure or surgery | Group IV |
Primary outcome
Percentage decrease of ulcer size twelve weeks after treatment begin (i.e. first shock wave treatment) compared to the baseline (ulcer size at first treatment)
3 secondary outcomes
Rate of completely healed ulcer 6, 9 and 12 weeks after first treatment
Percentage decrease of ulcer size 6 and 9 weeks after first treatment
Tissue oxygen concentration after shock wave treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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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.
Hans Gollwitzer, PD Dr., CCRP principal investigator
Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave in people with Chronic Diabetic Foot Ulcers, run by Technical University of Munich at 1 site in Germany.
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 5 inclusion and 25 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: withdrawn, as of the sponsor's last update on 19 Mar 2013. 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 Germany. 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 withdrawn before enrolling participants, so there are no results.
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?
Percentage decrease of ulcer size twelve weeks after treatment begin (i.e. first shock wave treatment) compared to the baseline (ulcer size at first treatment). 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 19 Mar 2013.