Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Diabetic Foot Primary Health Care

Outcome Measures

Primary Outcomes (6)

Percentage of individuals with diabetes mellitus who have undergone examination and exploration of both feet
Number of individuals with diabetes mellitus who have undergone examination and exploration of both feet.
Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have undergone foot risk stratification.
Number of individuals with diabetes who have undergone foot risk stratification.
Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have received group education related to diabetic foot care.
Number of individuals with diabetes who have received group education related to diabetic foot care.
Pre (baseline period) and Post-intervention (6-month)
Quality of life of individuals with diabetes
Quality of life of individuals with diabetes pre and post intervention measured through the COOP-WONCA questionnaire. The COOP/WONCA questionnaire was originally developed by a group of primary care physicians at The Darmouth Primary Care Cooperative Information Project (COOP Project), Hanover, New Hampsshire USA. The questionnaire consists of 9 items with a 5-point Likert-type scale. , where higher scores express worse levels of functioning. It was in 1988 when the World Organization of National Colleges, Academies, and Academic Associations of General Practitioners/Family Physicians (WONCA) adopted this instrument.
Pre (baseline period) and Post-intervention (6-month)

Secondary Outcomes (8)

Number of Primary Care teams where the sensitization and training strategy has been implemented.
Post-intervention (6-month)
Satisfaction level of professionals regarding sensitization and training
Post-intervention (6-month)
Percentage of professionals who have implemented the protocol after training.
Pre (baseline period) and Post-intervention (6-month)
Number of individuals detected with at-risk feet.
Pre (baseline period) and Post-intervention (6-month)
Number of individuals detected with diabetic foot.
Pre (baseline period) and Post-intervention (6-month)
+3 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group of patients will be attended according to a diabetic foot care protocol implemented in Primary Care in Salamanca. In addition, those patients and/or caregivers will receive group education sessions on Diabetic Foot Care at the Health Centers.

Other: Diabetic foot care protocolOther: Group education sessions for patients and/or caregivers

Control Group

NO INTERVENTION

Usual care

Interventions

Diabetic foot care protocolOther

Introduction of the diabetic foot care protocol in Primary Care in Salamanca, sensitization, and training of nursing professionals in Health Centers (HC).

Intervention Group

Group education sessions for patients and/or caregiversOther

Conducting group education sessions for patients and/or caregivers on Diabetic Foot Care at the Health Centers.

Intervention Group

Eligibility Criteria

Age14 Years - 99 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Individuals included in the "Care for individuals with DM" Service of the Primary Care Services Portfolio of SACYL, aged 14 years and older.

You may not qualify if:

Sponsors & Collaborators

Sanidad de Castilla y León
Otherlead

Study Sites (1)

Marta Manzano García

Salamanca, 37007, Spain

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes Complications

Study Officials

Marta Manzano García
Sanidad de Castilla y León
PRINCIPAL INVESTIGATOR

Enrollment

25,631 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal investigator

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 8, 2024

Study Start

March 1, 2023

Actual (reported)

Improvement of Diabetic Foot Care in Salamanca Through the Implementation of Standardized Protocols.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (8)

Study Arms (2)

Intervention Group

Control Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Improvement of Diabetic Foot Care in Salamanca Through the Implementation of Standardized Protocols.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (8)

Study Arms (2)

Intervention Group

Control Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations