Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)

NCT07004179 | Not Yet Recruiting

• 1 other identifier: PI06_2024
• Study Type: interventional
• Target: 1,520
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this two-arm cluster randomised controlled trial (RCT) is to evaluate the effectiveness of a new implementation strategy based on the ImM model for the Protocol of assistance to the person with diabetic foot (PAPDF) of the Balearic Islands Health Service in reducing complications of diabetic foot, compared to the current implementation strategy, in the primary care centers of Majorca. As secondary objectives we aim 1. To determine the reach of the implementation strategy in the GAPM primary care centers, 2.To compare the effectiveness of the PAPDF versus usual care in preventing diabetic foot complications, 3. To identify the number of healthcare professionals adhering to the implementation strategy and 4. To assess the sustainability of the implementation strategy over time.

Conditions

Diabetic Foot Disease; Diabetic Foot Ulcer (DFU)

Keywords

Diabetic foot; Implementation Sciencie; Prevention; Primary Care

Outcome Measures

Primary Outcomes (1)

• Reach

  Percentage of patients with diabetes mellitus over 18 years of age who have the "Diabetic Foot Protocol" open in the electronic medical record divided by the total number of patients with DM over 18 years of age in the health centers of both groups.

  At baseline, 6 months and 12 months.

Secondary Outcomes (4)

• Effectiveness

  At baseline, 6 months and 12 months.

• Adoption

  At baseline, 6 months and 12 months.

• Implementation fidelity

  At baseline, 6 months and 12 months.

• Maintenance

  At baseline, 6 months and 12 months.

Study Arms (2)

Implementation Mapping strategy

EXPERIMENTAL

Primary care centers, participants and caregivers assigned to this group will be part of an intervention designed to adopt an implementation strategy that will enhance the effective integration of the Diabetic Foot Care Protocol by reducing the complications associated with diabetic foot.

Current implementation strategy for diabetic foot prevention

SHAM COMPARATOR

Primary care centers, along with the participants and caregivers assigned to this group, will be integrated into routine care to prevent complications associated with diabetic foot.

Other: Sham Comparator

Interventions

Implementation strategy developed using the Implementation Mapping model to enhance the effective integration of the Protocol for Assistance to People with Diabetic Foot BEHAVIORAL

The intervention will be based on the Implementation Mapping methodology (IM). This model is based on the Intervention Mapping. IM consists of several specific tasks: 1. Conduct an assessment of needs and identification of programme adopters and implementers through a review of qualitative or mixed studies assessing the perceptions of both patients and professionals regarding DF prevention as well as individual semi-structured interviews with patients, health professionals and management staff 2. Indicate adoption and implementation outcomes and action objectives, identifying determinants and create matrices of change; this process will allow for the identification of determinants, which are those factors that influence the actions will be implemented 3. Select theoretical methods and select or design implementation strategies using the ERIC model (Expert Recommendations for Implementing Change) 4. Produce implementation protocols and materials 5. Evaluate implementation results

Sham Comparator OTHER

Usual care: No systematic implementation of the protocol based on the prevention of foot at risk, ulcer treatment and screening of the risk of diabetic foot ulcer for referral to hospital care.

Current implementation strategy for diabetic foot prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 1 or type 2 diabetes mellitus.
• Aged 18 years or older.
• Attending nursing consultations at participating primary care centers during the study period.

You may not qualify if:

• Patients with gestational diabetes.
• Patients with diabetic foot ulcers prior to the start of the study.
• Patients with lower limb amputations prior to the start of the study.

Sponsors & Collaborators

• University of the Balearic Islands: lead
• Universitat de les Illes Balears: collaborator

Study Sites (1)

Gerència d'Atenció Primària de Mallorca, Palma De Mallorca, Balearic Islands 07002

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Miquel Bennasar-Veny, PhD

CONTACT

0034971172367; miquel.bennasar@uib.es

Blanca Riquelme-Gallego, PhD

CONTACT

blanca.riquelme@uib.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: September 1, 2025
• Primary Completion: December 22, 2025
• Study Completion (Estimated): December 22, 2026
• Last Updated: June 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)