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NCT04652999
Relaxation Intervention in Patients With Diabetic Foot Ulcer
NA trial testing Muscle Relaxation with Guided Imagery in Diabetes Mellitus in 54 participants. Completed in 30 November 2021.
30 September 2021
Quick facts
| Lead sponsor | University of Minho |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 19 March 2019 |
| Primary completion | 30 September 2021 |
| Estimated completion | 30 November 2021 |
| Sites | 2 locations across Portugal |
Drugs / interventions tested
- Muscle Relaxation with Guided Imagery
- Neutral Guided Imagery
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
Sponsor
University of Minho
Who can join
18 and older, any sex, with Diabetes Mellitus or Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Psychological interventions can contribute to the improvement of wound healing and, relaxation, in particular, seems to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular on chronic wounds such as DFU. This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - EG) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), to inform a future definitive Randomised Controlled Study (RCT) that tests its effectiveness. This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the care system of multidisciplinary diabetic foot consultations. Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the three conditions - EG, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted with patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care. The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04652999
- Europe PMC full search
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Related trials
Other trials of Muscle Relaxation with Guided Imagery
Trials testing the same drug.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04652999 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Minho
- Last refreshed: 19 May 2022
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