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van CCT (UK)


Total contact versus Total contact Softcast in treatment neuropathic plantar ulcers.


- candidate number25642
- NTR NumberNTR6142
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-dec-2016
- Secondary IDs61960 ABR-nummer
- Public TitleTotal contact versus Total contact Softcast in treatment neuropathic plantar ulcers.
- Scientific TitleTCC versus TCS
- ACRONYM
- hypothesisA TCS is comparable to TCC and an effective treatment in neuropathic forefoot ulcer,
- Healt Condition(s) or Problem(s) studiedDiabetic foot, Ulcers
- Inclusion criteriaage >18 years old, mental competence and understanding of the Duth language
Diagnosis: Neuropathic ulcers without sign of ischemia, ability to walk more than 20 meters, wound depth tissue losts grade D1 and D2 according tot PEDIS I1 and I2
- Exclusion criteriapatients with a Charcot deformity, excessive edema of the lower leg, immobility (<20 meters)
an ankle brachial pressure index<0.9 and clinical signs of wound infection.(wound classification according to PEDIS Classification)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 31-jan-2017
- planned closingdate4-apr-2018
- Target number of participants76
- InterventionsTotal Contact Cast
- Primary outcomeResults of ulcer-healing equally well for TCS, as compared to TCC? When looking AT THE PERCENTAGE OF ULCER-HEALING AT 12 WEEKS FOLLOW UP.
- Secondary outcomeTime to wound healing
validated Quality of life score.
- Timepointspatients visit the outpatient clinic weekly for a cast change and wound inspection by a wound nurse.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES B.P. Vierhout
- CONTACT for SCIENTIFIC QUERIES B.P. Vierhout
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryA Total Contact Softcast (TCS) is a new alternative treatment for patients with a forefoot ulcer. An increasing number of Hospitals in the Netherlands use a TCS or the Total Contact Cast (TCC): the golden standard for off-loading. Patients have a better comfort in a TCS instead of a TCC, resulting in an easier walking pattern. Cast technicians observe adequate healing of the wounds. A comparison between both techniques was never made (to our knowledge). A TCS relieves multiple possible causes prohibiting mobilization. It may shorten the treatment duration and increase the quality of life. The impact of excessive pressure on the sole of the foot in the pathogenesis of neuropathic plantar ulcers, is well established. It is also known that complete relief of pressure from the ulcerated area is the key to effective healing. A non-removable Total Contact Cast is the golden standard for off-loading ulcers located at the forefoot or midfoot. Patients walk for weeks or several months with a TCC: After 12 weeks resulting in 90% healing of the patientsí wounds. This non-removable knee-high device, including ankle joint immobilization, reduces the activity level with a potential risk of falls and knee or hip complaints due a provoked asymmetry in walking. Early discontinuation because of inconvenience of the TCC was seen in 21% of the patients. The use of a TCC is contraindicated, in patients with infection or critical ischemia. A relative contraindication is found in elderly, patients with visual or equilibrium problems, and patients with a contra lateral foot ulcer or varicose veins. Other reasons for discontinuation are pressure points and joint problems in 7% of the patients. Also ankle stiffness and lower back pain disturb the walking pattern. In a Total Contact Softcast the ankle is wrapped in a semi-rigid stretch bandage allowing movement of the ankle joint. The sole is constructed of a rigid cast. This allows a normal walking pattern combined with off-loading of pressure points of the wounds. The World Health Organization (WHO) defines disability as one of the problems an individual may experience in functioning. This may be positively influenced by the accomplishment of a physically active lifestyle with a semi-rigid cast: A TCS.
- Main changes (audit trail)
- RECORD8-dec-2016 - 17-mei-2017


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